CDSCO risk classification
General Hospital/Orthopedics medical device classification
Every general hospital/orthopedics device in CDSCO's classification register, with its risk class under the Medical Devices Rules, 2017 and its intended use. 199 are Class A non-sterile, non-measuring devices, which are exempt from licensing but must be registered.
- Devices
- 454
- Class A
- 279
- Class B
- 71
- Class C
- 85
- Class D
- 19
General Hospital/Orthopedics devices and their class
454 devices
3 way stop cock as an accessory to perfusion sets
General Hospital/Orthopedics
Class BIt is indicated for fluid flow directional control and for providing access port for administration of solution, withdrawal of fluid and pressure monitoring.
A hip joint (hemi-hip) acetabular metal cemented prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted to replace a portion of the hip joint.
Abdominal support/belt/binders, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to hold abdominal muscles together to relieve pain and increase circulation at surgical site to promote healing and decrease swelling. May also make physical activity more comfortable.
Abdominal support/belt/binders, single use
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile, disposable device Intended to hold abdominal muscles together to relieve pain and increase circulation at surgical site to promote healing and decrease swelling.
Abdominal/ENT/orthopaedic surgical probe, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions it does not include stereotactic devices and is not dedicated to endoscopy. This is a reusable device.
Absorable Hemostatic Based
General Hospital/Orthopedics
Class DAn absorbable haemostatic agent or dressing is a device intended to produce haemostasis by accelerating the clotting process of blood. It is absorbable.
Absorbent Cotton wool
General Hospital/Orthopedics
Class AIt is intended to used for applying medication to, or absorbing small amounts of body fluids.
Absorbent cotton wool, non- sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be used for applying medication to, or absorbing small amounts of body fluids.
Absorbent underpad, antimicrobial
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA flat piece of absorbent fabric material intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures or incontinence. It may include an antibacterial agent [e.g., silver (Ag)] and typically helps to eliminate unwanted odours (not for ancillary therapeutic action). It is intended to be used in the healthcare facility and in the home.
Absorbent Underpad, non- antimicrobial
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile absorbent fabric intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence). It may be intended for home-use or/and hospital settings.
Acoustic Stethoscope
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA mechanical listening device used for listening to sounds from the heart and lungs and their qualitative assessment.
Adhesive plaster (Zinc oxide adhesive plaster)/Tape
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to secure dressings and for strapping on intact skin.
Adhesive Plaster B.P.’ 88 (Zinc Oxide Adhesive Plaster)
General Hospital/Orthopedics
Class AIt is intended to secure dressings and for strapping on intact skin.
Adhesive strip
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA flexible strip (of fabric, plastic, paper, or other material) coated on one side with a pressure- sensitive adhesive, typically used to cover or approximate the edges of superficial wounds or fix dressings to skin. The device may include an adhesive pad and have qualities such as waterproof.
Adhesive tape remover
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to help reduce pain and ease removal of medical adhesives used in stoma care products, dressings and other medical appliances from the skin surface.
Adhesive Tape USP
General Hospital/Orthopedics
Class AIt is intended to secure dressings and for strapping on intact skin .
Adult Incontinence Pants/Diaper
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA disposable undergarment (a nappy or diaper) intended to be worn between the legs used to collect urine and faeces from an incontinent adult patient.
Aerosol adhesive for compression garments
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA sticky substance intended to be applied on the skin to anchor compression garments in place.
Air cushion/Pressure relief cushions
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to relieve pressure on an affected area when a person has hemorrhoids or when he has undergone surgery in the back or buttock area/prevention of pressure sores/ulcers in patients.
Alarm, bed occupancy
General Hospital/Orthopedics
Class ANon-sterile, non-measuringBed Floor Mat/Crash Mat Alarm/Alert Patient Movement
Alcohol swab
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile absorbent swab containing alcohol intended for cleaning and scrubbing of needle access sites.
Alcohol Swabs
General Hospital/Orthopedics
Class AIt is a single use, sterile device containing 70% Isopropyl alcohol used for scrubbing and allowing drying and will disinfect needless access sites prior to use.
Alignment Guide
General Hospital/Orthopedics
Class AA reusable manual surgical instrument designed to facilitate the correct orientation (alignment) of another medical device or implant during orthopaedic surgery.
Alternating-pressure bed mattress
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA mattress-like device intended to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and to connect to a pump (not included) to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores.
Alternating-pressure bed mattress overlay, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile pad or thin mattress, usually full- body length, which is intended to be placed on top of a bed mattress to actively change an occupant's bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores, decubitus ulcers, etc. in elderly immobilized, patients with disabilities, or patients with low body fat. This is a reusable device.
Alternating-pressure bed mattress overlay, single-use
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile, disposable pad or thin mattress, usually full-body length, which is intended to be placed on top of a bed mattress to actively change an occupant's bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores, decubitus ulcers, etc. in elderly immobilized, patients with disabilities, or patients with low body fat.
Ambulance stretcher loader
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA battery-powered, hydraulically-operated device designed to be installed within an ambulance to support the loading and unloading of an ambulance stretcher, to improve the safety and ease of patient transfer to and from the ambulance.
Ambulance stretcher, electrohydraulic/pneumatic
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA pneumatic or hydraulically-operated device intended for use by healthcare personnel primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles. Ambulance-mounted locking/docking devices may be included.
Ambulance stretcher, manual
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manually-operated device intended for use by healthcare personnel primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles. It also usually includes locking devices that match with the locking/docking devices in the ambulance.
An interarticular disc prosthesis
General Hospital/Orthopedics
Class DIntended to be an interface between the natural articulating surface of the mandibular condyle and glenoid fossa.
Ankle joint metal/composite semi-constrained cemented prosthesis
General Hospital/Orthopedics
Class CAn ankle joint metal/composite semi- constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint.
Ankle joint metal/polymer non-constrained cemented prosthesis
General Hospital/Orthopedics
Class CA device intended to be implanted to replace an ankle joint. The device limits minimally translation in one or more planes. It has no linkage across-the-joint.
Antiseptic generation system
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for generation/synthesis of disinfectant at the point-of-care (onsite) for wound irrigation and management.
Apgar timer
General Hospital/Orthopedics
Class AThe Apgar timer is a device intended to alert a health care provider to take the Apgar score of a newborn infant.
Approximator
General Hospital/Orthopedics
Class AA surgical instrument having a shaft-like handle, which tapers as it approaches its distal end. The distal portion of the instrument is curved towards its tip which culminates in a pointed end that is intended to grasp tissue and retract it during a surgical procedure. These include Tibia /femur distal approximator.
Arm board, pediatric
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to immobilize and hold steady infants’ limbs when securing intravenous lines.
Arthroscopes
General Hospital/Orthopedics
Class BAn arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
Arthroscopic Instruments
General Hospital/Orthopedics
Class BThese are surgically invasive instruments for manipulating and removing bone and bone fragments. Intended to used in orthoscopic surgical procedure.
Artificial airway washing/disinfection jar
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA container intended to hold artificial airway devices to facilitate their washing/disinfection. This is a reusable device and does not include disinfectants.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Aspiration Needle
General Hospital/Orthopedics
Class BUsed for either laparoscopic aspiration or injection.
Aspiration Syringe
General Hospital/Orthopedics
Class BUsed for either laparoscopic aspiration or injection.
Assistive coverall
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA lightweight wrap specially designed/adapted to be used by a person with a disability to cover and protect them against precipitation (rain, snow, sleet), cold and wind, especially when using a wheelchair, pram, or sledge.
Auto Disable Syringe for single use
General Hospital/Orthopedics
Class BIntend to inject fluids into or withdraw fluids from the body.
Auto-disable (AD) syringes for immunization
General Hospital/Orthopedics
Class BIntend to inject fluids into or withdraw fluids from the body.
Autopsy saw with/without vacuum filtration unit
General Hospital/Orthopedics
Class ANon-sterile, non-measuringintended to be used during autopsies on cadavers for bone cutting. It may have a vacuum filtration unit for collection of dry bone dust and debris.
Autopsy/dissection table, mechanical/electric
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA device intended to provide a working surface for the examination and dissection of organs and other anatomic parts mostly during postmortem pathologic investigations and for demonstration purposes. Not for use during surgical/diagnostic procedures on living humans.
Bandage scissors, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringHeavy scissors for cutting pads, plaster and plastic rail associations.
Bariatric table/bed
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to accommodate and support a bariatric (obese) patient whose body mass exceeds the safe working load of standard hospital/institution beds and trolleys. This does not have any other therapeutic/measuring or diagnostic function. This may be electrically adjusted.
Basket stretcher
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to transfer patients in emergency situations such as in the mountains, and marine offshore application.
Bath towelette
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile, disposable device intended for use in healthcare settings to clean and wipe the skin of patients who are immobile or bedridden due to surgery, injury, paralysis, sepsis, critical illness, etc., or for those with surgical wounds/drains (where water contact needs to be minimized). May also be used on pediatric and immunocompromised patients.
Bed board
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA flat, stiff device intended to increase the firmness of a hospital bed's mattress to provide an appropriate rest surface for the user typically with spinal problems.
Bed exit monitor, Fall prevention
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be placed under mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.
Bedside screen
General Hospital/Orthopedics
Class ANon-sterile, non-measuringGeneral-purpose, non-sterile, hospital-use device intended to create a partition in order to conceal a patient in a bed or examination table during medical procedures (not intended for maintaining sterile field).
Bender
General Hospital/Orthopedics
Class AA reusable surgical instrument used to bend medical device, typically those for implantation to the appropriate anatomical fit.
Biohazard spill clean-up kit
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA set of non-sterile devices intended for use in hospital settings to clean up and dispose infectious material (such as blood, urine, vomit, etc.), a mercury (Hg) spillage due to thermometer/device breakage, etc., hazardous chemical spills (such as formalin, etc.), in a safe manner.
Bite block, endoscopy, non- sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA reusable device intended to be inserted in a patients mouth to maintain oral patency and protect both the patient and the endoscope (not included), when an endoscope is inserted into a patients mouth for a procedure. It does not have any additional functionality.
Blood bags with anticoagulant
General Hospital/Orthopedics
Class CIt is indicated for the collection of human blood and the preservation of blood components.
Blood bags without anticoagulant
General Hospital/Orthopedics
Class CIt is indicated for the collection of human blood and the preservation of blood components.
Blood bank centrifuge
General Hospital/Orthopedics
Class AIntended to separate blood components of a suspension by application of centrifugal force.
Blood Collecting Needle
General Hospital/Orthopedics
Class BIntended to be used with evacuated blood collection tube for collection of venous blood.
Blood storage refrigerator
General Hospital/Orthopedics
Class BThsese are devices intended for medical purposes that are used to preserve blood and blood products by storing them at cold or freezing temperatures.
Blood transfusion chair/couch
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA height-adjustable device intended to position the patient in such a manner that a technician/nurse has easy access to the patients arm for drawing blood. Blood drawing equipment is not included.
Body waste receptacle
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.
Bolster Suture
General Hospital/Orthopedics
Class ANon-latex plastic bolsters are used to hinder pressure of any temporary suture against the body during surgery.
Bone cap
General Hospital/Orthopedics
Class CIntended to be implanted to cover the end of a bone.
Bone cement
General Hospital/Orthopedics
Class CIntended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.
Bone cement accessories
General Hospital/Orthopedics
Class BCement Accessories are devices used in conjunction with bone cement to facilitate its handling and penetration into a bone site. Accessories include devices for scrubbing and drying a bone cavity, plugging the cavity to contain the cement in the desired location, hand- or vacuum-mixing the cement, inserting the cement into the prepared cavity, pressurizing the cement to ensure adhesion to the bone, and removing excess soft cement after implantation of prosthetic components. Bone cement/implant not included.
Bone Chisel
General Hospital/Orthopedics
Class AA single bladed surgical instrument, bevelled on one side, that is intended for use in cutting or contouring bone. Widely used in orthopaedic surgery.
Bone Curette
General Hospital/Orthopedics
Class AA hand held manual surgical instrument used for cutting and excising bone tissue typically during orthopaedic surgery. It is typically a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end. The bowl may be open (ring currette) or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. This is a reusable device.
Bone curette, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual surgical instrument intended for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure without causing trauma to the surrounding muscles. This is a reusable device.
Bone Cutter
General Hospital/Orthopedics
Class AA surgical instrument used to cut bone to penetrate/separate bone, during orthopaedic surgical procedures.
Bone cutting forceps, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held, surgical instrument intended for cutting posterior rib ends and bone tissue during a surgical procedure. This is a reusable device.
Bone file/rasp, manual, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to scrape and smooth the surface of bone during a surgical procedure It is not dedicated for use at a specific anatomy (e.g., sinus, ear). This is a reusable device.
Bone grafting material
General Hospital/Orthopedics
Class CIntended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Bone heterograft
General Hospital/Orthopedics
Class DIntended to be implanted that is made from bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
Bone holding forceps, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual surgical instrument intended to grasp and hold a bone during an open surgical procedure. This is a transient-use, reusable device.
Bone hook/ Bone retractor, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held, surgical instrument intended for hooking around or into bone, typically to grasp, hold, and apply traction to the bone during a surgical intervention. This is a reusable device intended for transient use.
Bone marrow cell separator
General Hospital/Orthopedics
Class BIt is a general lab equipment to be used to isolate target cells and cells concentrate from bone and blood.
Bone Marrow Needle
General Hospital/Orthopedics
Class BNeedle inserted in Bone Marrow to collect sample.
Bone nail driver, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to impart force on another instrument or directly on a bone fixation nail to insert the nail into tissue (i.e., to drive the nail into the intramedullary canal). This is a reusable device intended for transient use.
Bone Tap
General Hospital/Orthopedics
Class AA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. The product does not include orthopaedic implants.
Bone tap, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual surgical instrument intended for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). This is a reusable device.
Bone wax/Haemostat
General Hospital/Orthopedics
Class CTo stop bleeding at bones in orthopaedics and traumatology, thoracic surgery, dental, oral jaw surgery, neurosurgery.
Bone Wire
General Hospital/Orthopedics
Class CIntended to be used for bone stabilization in the hand and wrist.
Bowl stand
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to store and hold medical bowls. Intended for hospital use.
Box Wrench for Nut/Bolt
General Hospital/Orthopedics
Class AA minimally invasive, reusable surgical instrument intended to grip, twist or turn nut and bolt.
Burn sheet
General Hospital/Orthopedics
Class AInteded to wrap around a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants
Cardiac compression board
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA flat, rigid device that is placed under a patient to act as a support during cardiopulmonary resuscitation.
Cardiopulmonary resuscitation board
General Hospital/Orthopedics
Class AIntended to be placed under a patient to act as a support during cardiopulmonary resuscitation.
Cast cutter vacuum system
General Hospital/Orthopedics
Class ANon-sterile, non-measuringAn assembly of devices intended to collect the dust produced by a cast cutter (e.g., pneumatic or electric cast saw) from the workspace environment by suction during the cast removal procedure. It is not intended for surgical/on- patient use.
Cast cutting scissors
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held surgical instrument intended to cut small plaster cast dressings and layers of thick material, e.g., bandages. This is a reusable device.
Casting tapes/Splint Rolls
General Hospital/Orthopedics
Class BA prosthetic and orthotic accessory, intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis.
Cervical Artificial Disc
General Hospital/Orthopedics
Class DCervical Artificial Disc is indicated for reconstruction of the disc.
Cervical disc spacer instruments for Spine
General Hospital/Orthopedics
Class AIntended to be used in cervical disc surgery. The products include Rasp for cervical disc spacer, Graft seat holder for cervical disc spacer, Bone tamp for cervical disc spacer & Lateral mass system & small anatomical system instruments. The product does not include orthopaedic implants.
Cervical plate system instruments
General Hospital/Orthopedics
Class AThe Cervical plate system instruments is a comprehensive system of instruments for stabilization of the spine in the cervical regions. The instruments used by surgeon includes pin fixation, plate bender, supporting pin for cervical plate, Screw Tightner for Cervical Plate Screw, Knob Aligner for Cervical Lock Plate, Plate Holder for Cervical Lock Plate, Threaded Pin. The system does not include orthopaedic implants.
Chemical cold pack snakebite kit
General Hospital/Orthopedics
Class DIntended for first-aid treatment of snakebites
Chemotherapy spill clean-up kit, non-sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to safely clean and dispose of Chemotherapy drug spills. All components are supplied non-sterile.
Chisel/osteotome blade handle
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical device that is intended to function as a handle that mounts a compatible chisel/osteotome blade of these types which is locked into place. This is a reusable device.
Cholera bed
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended as a physical suppport for severely ill and weak patients including those suffering from cholera.
Clamp
General Hospital/Orthopedics
Class AResuable Handheld Surgical Instrument for clamping tissues or materials or bone. These include Clamp for holding pins.
Cleaning solution for medical devices
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be used prior to disinfection for cleaning of medical devices such as dental suction units, etc. It is not a disinfectant for medical devices.
Clinical color change thermometer
General Hospital/Orthopedics
Class AA clinical color change thermometer is a disposable device used to measure a patients oral, rectal, or axillary (armpit) body temperature.
Computer Assisted Surgery System
General Hospital/Orthopedics
Class BImage guided instruments are intended for planning and intraoperative navigation during surgical procedures where the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure such as a long bone can be identified relative to a CT or MR based model or fluroscopy images of the anatomy. The instruments when used in conjunction with the navigational software allo real time tracking with three-dimensional visualization of the surgical field.
Container for orthopaedic cement dispensor
General Hospital/Orthopedics
Class AA sterile device in which an orthopaedic cement dispenser is placed to maintain the sterility of the dispenser and its contents when it is taken out of the sterile field to be mixed. The product does not include orthopaedic implants.
Continuous Glucose Monitoring System
General Hospital/Orthopedics
Class CA collection of devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, subcutaneous or percutaneously-inserted electrode(sensor), a transmitter, and/or a monitor or receiver that captures, stores, and converts the sensor signals to glucose concentrations for display. It may also consist of compatible software applications for continuous display of glucose levels and trend anaylsis. The system may aid in the detection of episodes of hyperglycemia and hypoglycemia, facilitating acute/long-term therapy adjustments.
Corn/callus dressing, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringThe device is intended to offer symptomatic relief of physical foot disorders and similar conditions, by providing a mechanical barrier which relieves the effects of pressure and friction and or support.
Corn/callus dressing, single use
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile adhesive dressing intended for protection and/or relief of corns or calluses (hardened areas of skin on the feet or toes).
Cortical Fixation Implant/rigid loop Adjustable Cortical Fixation System
General Hospital/Orthopedics
Class CCortical Fixation System is a machined titanium implant designed to provide fixation in the repair of tendons and ligaments.
Cotton and Rubber Elastic Bandage
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended for sprains, strains and painful joints on intact skin.
Cotton Crepe Bandage
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended for sprains, strains and painful joints on intact skin.
Cotton Grudges
General Hospital/Orthopedics
Class AAdhesive bandages, Gauge bandages, Medical Absorbent (fiber) bandages.
Cover for thermometer probe, non-sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to act as a physical barrier between the patient and an in-the-ear thermometer to prevent cross-contamination between patients. This is a reusable device.
Craniofacial rongeur, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty) it is not dedicated to dental surgery. This is a reusable device.
Crash cart/Emergency recovery trolley
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for use in hospitals for transportation and dispensing of emergency medication/ equipment at the site of a medical/surgical emergency for life support protocols (equipment not included).
Depth Gauge
General Hospital/Orthopedics
Class ADevice intended to aid surgeon in determining the appropriate length retractor blade to use based on surgical site depth through a color-coded system.
Digital Thermometer
General Hospital/Orthopedics
Class BIt is device used to record the body temperature.
Dilator & accessories
General Hospital/Orthopedics
Class AA surgical instrument used for enlarging cavities or openings during surgical procedures. This include dilator incision.
Disinfectants
General Hospital/Orthopedics
Class BAn agent that destroys pathogenic and other kinds of microorganisms by chemical or physical means. A disinfectant destroys most recognized pathogenic microorganisms, but not necessarily all microbial forms, such as bacterial spores. It is intended to disinfect a medical device.
Dissector
General Hospital/Orthopedics
Class AA hand-held surgical instrument, usually spoon shaped or rounded at the working end made of stainless steel, used to separate a soft tissue or body structure from another. It comes in various shapes and sizes but usually has a handle proximally which continues into a shaft as one moves distally. The shaft terminates in a tip which may be pointed or flat, sharp or blunt and angled or straight from the shaft. These include tear drop dissector set & pen field dissector.
Dressing trolley
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to store and transport medical dressings within a hospital/health care facility. This does not include dressings.
Dry-heat sterilizer
General Hospital/Orthopedics
Class CA dry-heat sterilizer is a device that is intended for use by a health care provider to sterilize medical devices by means of dry heat.
Ear, nose, and throat and facial synthetic polymer material or implant
General Hospital/Orthopedics
Class CIt is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck.
Elastic Adhesive Bandage
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to secure dressings and for strapping on intact skin.
Elasticated Cohesive Bandage
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to secure dressings and for strapping on intact skin .
Elbow joint humeral (hemi- elbow) metallic uncemented prosthesis
General Hospital/Orthopedics
Class CA device intended to be implanted made of alloys, such as cobalt- chromium-molybdenum, that is used to replace the distal end of the humerus formed by the trochlea humeri and the capitulumhumeri.
Elbow joint metal/polymer constrained cemented prosthesis
General Hospital/Orthopedics
Class CAn elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint.
Elbow joint metal/polymer semi-constrained cemented prosthesis
General Hospital/Orthopedics
Class CAn elbow joint metal/polymer semi- constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint
Elbow joint radial (hemi-elbow) polymer
General Hospital/Orthopedics
Class CAn elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
Electric linear actuator with/without control box
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA device in its finished form, specifically designed and intended to control the movement of electric medical beds, operation tables, etc.
Electrical-only medical device connection adaptor
General Hospital/Orthopedics
Class ANon-sterile, non-measuringThis device connects incompatible plugs/sockets on related medical devices (e.g., video control centers, peripheral devices and controller) and/or cables and relates the control signals.
Electrical-only medical device connection cable, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-patient-contact, electrical cord with a connector (plug) at both ends intended to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
Electrically powered spinal fluid pressure monitor
General Hospital/Orthopedics
Class BInteded to measure spinal fluid pressure by the use of a transducer which converts spinal fluid pressure into an electrical signal.
Electrode/transducer strap, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface. This is a reusable device.
Electronic Drive Instruments & Accessories
General Hospital/Orthopedics
Class AThe electronic instruments used as orhtopaedic instruemnts. This includes Battery, Battery charger, Tubes for connecting to cuffs, Single cuffs for tourniquet, Double cuffs for tourniquet, High speed Motor control unit, Cutters & Burrs, Straight and Angled Handpieces, Craniotome, Perforator, light source cable, optic fibre cable. The system does not include orthopaedic implants.
Electronic monitor for gravity flow infusion systems
General Hospital/Orthopedics
Class CInteded to electronically monitor the amount of fluid being infused into a patient.
Electronically operated Tourniquet Single & Double Cuff Consol
General Hospital/Orthopedics
Class BElectronically operated Tourniquet used for stopping flow of blood through artery by compression. This unit include consol.
Elevator, orthopaedic, periosteal/ Periosteal elevator, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. This is a reusable device intended for transient use.
Elevator, orthopaedic/ Bone lever/elevator, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual surgical instrument intended to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. This is a reusable device intended for transient use.
Emesis bag
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA disposable device intended to collect and contain a patients vomit and eliminate exposure to vomit until it is convenient to dispose of the bag and its contents. Intended for hospital use.
Endoscope Storage Cabinet
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for storing (and drying) endoscopes after their disinfection and maintaning a microbe- free environment. This is not intended for disinfection or sterilization. This may be an accessory of a disinfector.
Endovascular suturing system
General Hospital/Orthopedics
Class CIt is a medical device intended to provide fixation and sealing between an endovascular graft and the native artery.
Environmental chamber for storage of platelet concentrate
General Hospital/Orthopedics
Class BA refrigerated environmental chamber for storage of platelet concentrate is a device used to hold platelet- rich plasma within a preselected temperature range.
Ethylene oxide gas sterilizer
General Hospital/Orthopedics
Class CIntended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical devices.
Extension Plaster –width wise stretchable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to secure dressings and for strapping on intact skin.
Extension Sets
General Hospital/Orthopedics
Class BExtension sets are sterile devices for single use only. They are intended to be used as part of a system for the infusion of fluids/medications in medical applications.
External Ring fixation system
General Hospital/Orthopedics
Class BThe Ring Fixation System consists of series of external fixators intended to be used to stabilize bone segment in a broad range of indications,including fractures, joint fusion, bone transport, lengthening & angular corrections. The system includes Half Rings 5/8 Ring, Rings With Curved Extremities, Italian Femoral Arches, Arches With Holes, Threaded Rods, Telescopic Rods, Post- Male/ Female, Hinges-Male/ Female/Standard, Long/Short Connection Plates, Connected Plates With Threaded Ends, Twisted/Curved Plates, Bushing Threaded Sockets, Connection Bolts, Nut, Washers, Bolt, Multiple, Wire Fixation Buckle, Blocks for Half Pins, Universal Joint, Rotational and Translational Device, Oblique Support, Set Screw, Foot Rings, Knurling post male. Implants not included.
Extractor
General Hospital/Orthopedics
Class AAn instrument, commonly known as a splinter probe, used to aid in the removal of foreign objects from superficial skin tissue. The device is single-use. These include Extractor rod, Extractor hammer, Extractor rod handle, Head extractor for cemented stem, Head extractor.
Fiber cast bandage
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be used as a medical dressing to support and protect bones that have been broken or joints that need stabilization.
Finger and toe bandage
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be worn over/around the limb (arm/leg) and/or finger of a patient affected by a skin condition/disorder (e.g., eczema, wound, fragile skin) to protect the skin typically after treatment with a medication (e.g., ointment, cream), and/or to support a dressing over a wound/injury.
Finger joint metal/metal constrained cemented prosthesis
General Hospital/Orthopedics
Class CA finger joint metal/metal constrained cemented prosthesis is a device intended to be implanted to replace a metacarpophalangeal (finger) joint.
Finger joint metal/metal constrained uncemented prosthesis
General Hospital/Orthopedics
Class CA device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint.
Finger joint polymer constrained prosthesis
General Hospital/Orthopedics
Class CA device intended to be implanted to replace a metacarpophalangeal or proximal interphalangeal (finger) joint.
Finger protector, non-sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA glove-like device intended to be worn on the finger(s) to protect fingers during insertion of devices such as suppositories (not included) through the body orifice(s). This is not intended for surgical purposes.
Fixation, non- absorbable for pelvic use
General Hospital/Orthopedics
Class CAttaching suture or stapling ligaments of the pelvic floor.
Fluid delivery mount, general-purpose
General Hospital/Orthopedics
Class ANon-sterile, non-measuringThe device is intended to hold the fluid bags when gravity irrigation is needed for scope surgery.
Fluid Management System
General Hospital/Orthopedics
Class BIrrigation pump with accessories for diagnostic and/or surgical arthroscopic procedures. It pumps medically sterile irrigation fluids through a sterile tube. These fluids are used to distend and irrigate corresponding body cavities to provide space and improve visibility for the surgeon. The products does not include implants.
Fluted surgical drill bit, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA shaft of metal intended to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This is a reusable, non-measuring device intended for transient use.
Footstool, conductive
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA conductive low stool for standing on to compensate for height differences. It is intended to be used in health care settings, e.g. examination rooms or operating theatres, etc..
Forceps
General Hospital/Orthopedics
Class AForceps are used to grasp, manipulate, compress, pull or join tissue, equipment or supplies. It includes burns for radius, modified burns, martins cartilage forcep, sequestum forcep, reduction forcep, self centering forcep, Fergussons Type Bone Holding forcep, Haygrooves Type Bone- Holding Forcep,Lanes Type Bone – Holding Forcep, Patella with Single Pronge, Patella Double Pronge, Patella with Eye, Rocker Forcep, Plate & Bone Holding Forcep.
Forceps jar
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA cylindrical vessel intended for holding various types of forceps prior to and during a surgical intervention or an examination in an operating room (OR) or examination room. This is a reusable device.
Forceps, bone, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to grasp, manipulate, cut or crush bone. This is a transient use, reusable device intended to be sterilized prior to use.
Forceps, general-purpose
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended for general-purpose grasping/picking up of other devices/objects typically with the intention of maintaining a sterile condition or avoiding direct hand contact because of unhygienic/unfavourable conditions. This is a reusable device.
Forceps, sterilizer transfer
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held, scissors-like, manual surgical instrument intended to grasp and handle sterile instruments, packages, or implants, especially directly from a sterilizer. This is a reusable device.
Forceps, wire/Wire holding/twisting forceps, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual surgical instrument intended to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. This is a reusable device.
Gas cylinder trolley
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA dedicated cart designed to hold and secure one or more medical gas cylinders of compressed gas (not included) but may be used for other types of gases, both during transport and static placement. Intended for hospital use.
General external orthopaedic fixation kit, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA collection of non-sterile, non-measuring, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes include instruments, such as retractors, rods, clamps, drills, saws, screwdrivers, guides, impactors, intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated) it does not include any implantable devices. The surgically invasive components of this kit are intended for transient use only.
General internal orthopaedic fixation system implantation kit, reusable, non-measuring
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-dedicated collection of hand-held, manual, non-measuring instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial).It includes reusable devices for transient use [retractors, rods, clamps, drills, guides, saws, screwdrivers, impactors, etc.] the implant(s) is not included. This is a reusable device.
Glenoid fossa prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted in the temporomandibular joint to augment a glenoid fossa or to provide an articulation surface for the head of a mandibular condyle.
Haemostatic Gelatine Sponge /Haemostat
General Hospital/Orthopedics
Class CIntended for the control of surface bleeding from vascular access sites and percutaneous catheters or tubes.
Hand-carried stretcher
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-carried stretcher is a device intended to carry patient as an assistance for injury or disability.
Handgrip cover for vein illumination device
General Hospital/Orthopedics
Class ANon-sterile, non-measuringThe cover is intended to isolate vein illumination devices and simplify cleaning after use.
Heat-sealing device
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.
Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted to replace the head and neck of the femur.
Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted to replace a portion of the hip joint.
Hip joint femoral (hemi-hip) metallic resurfacing prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted to replace a portion of the hip joint
Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted to replace the head and neck of the femur.
Hip joint metal constrained cemented or uncemented prosthesis
General Hospital/Orthopedics
Class DA hip joint metal constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint.
Hip joint metal/ceramic/polymer semi- constrained cemented or nonporous uncemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a hip joint
Hip joint metal/composite semi- constrained, cemented prosthesis
General Hospital/Orthopedics
Class CA hip joint metal/composite semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace a hip joint
Hip joint metal/metal semi- constrained, with a cemented acetabular component, prosthesis
General Hospital/Orthopedics
Class DIt is a prosthesis intended to be implanted to replace a hip joint.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Hip joint metal/metal semi- constrained, with an uncemented acetabular component, prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted to replace a hip joint
Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a hip joint
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Hip joint metal/polymer constrained cemented or uncemented
General Hospital/Orthopedics
Class DIntended to be implanted to replace a hip joint
Hip joint metal/polymer constrained cemented or uncemented prosthesis
General Hospital/Orthopedics
Class DA hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint
Hip joint metal/polymer or ceramic/polymer semiconstrained resurfacing cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace the articulating surfaces of the hip while preserving the femoral head and neck
Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a hip joint
Hip prosthesis socket pusher
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to hold an acetabular cup or shell at the distal end. It may be used to force the acetabular component of a total hip prosthesis into the proper position in the acetabular vault of the pelvis. This is a reusable device.
Hip System Instrument
General Hospital/Orthopedics
Class BThese are surgically invasive instruments which are used manually to assist in the implantation of the femoral or acetabular components in total or hemiarthroplasty. The devices are single use/reusable. The product does not include orthopaedic implants.
Hook
General Hospital/Orthopedics
Class AA handheld reusable instrument used to hold tissues or to pull tissues around.
Hospital Backrest
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to support patients with spinal problems and pain management.
Hospital bed remote control (hand-operated/foot operated)
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to control the operation and movement of hospital beds, operation tables, medical chairs/couches, etc.
Hospital Bedside cabinet
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA console by a patients bed in a hospital/healthcare institution, that may contain storage shelves, open storage space, drawers, radio, and nurse/call units.
Hospital Linen trolley
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to transport linen, that may or may not be soiled, from a patient ward to laundry and vice versa. Intended for hospital use.
Hydraulic adjustable hospital bed.
General Hospital/Orthopedics
Class AIntended for medical purposes that consists of a bed with a hydraulic mechanism operated by an attendant to adjust the height and surface contour of the bed.
Hydrogen Peroxide Gas Plasma Sterilization System
General Hospital/Orthopedics
Class CIntended for sterilization/disinfection of both metal and nonmetal/polymer based medical devices.
I V Flow regulator
General Hospital/Orthopedics
Class BAn IV system and administration device offering precision care and consistent delivery.
ICU Bed, mechanical/electric
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be used as a patient bed in the intensive care unit of a hospital/health care facility, and which may be motorized providing the patient/nursing staff with ability to adjust the bed positioning or height. This does not have a measuring function.
Implant Trials
General Hospital/Orthopedics
Class BTrials are temporary sizing guides which are used by surgeons to check the size and fit of orthopaedic implants before actual implantation of device. The product does not include orthopaedic implants.
Inflatable patient transfer sliding mattress
General Hospital/Orthopedics
Class ANon-sterile, non-measuringAn inflatable device intended to support a recumbent patient on a bed or table and assist in the physical movement of a patient for safer, easier transfer and positioning in Trendelenburg and Reverse Trendelenburg.
Infusion Pump or Elastomeric Infusion Device
General Hospital/Orthopedics
Class CThe Infusion Pumps intended for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intra-operative site or subcutaneously for post operative pain management.
Ingestible event marker
General Hospital/Orthopedics
Class CAn ingestible event marker is a prescription device used to record time-stamped, patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device.
Injector Type actuator syringe
General Hospital/Orthopedics
Class CA syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal.
Insertion and removal instruments
General Hospital/Orthopedics
Class AReusable surgical instruments to facilitate the manipulation, implantation and removal of various orthopaedic devices during orthopaedic surgeries.
Instrument set for Bone Screws & Plates
General Hospital/Orthopedics
Class AThe instrument set fore bone screw & plates includes Tap, Countersink shaft, Tension device Muller type, handle for quick coupling, holding clip, Dynamic Compression Plate/Limited Contact Dynamic Compression Plate neutral & load guide, bending iron for plates, bending iron for k-wires, Direct measuring device, threaded plate holder , Push pull reduction device, Tension device Muller type, Bending pin, Refractor. The product does not include orthopaedic implants.
Instrument set for external fixation system
General Hospital/Orthopedics
Class AThe instrument used for external fixation system. These include screw guide, allen key, half pin introducer, jig for fixator, minimally invasive spine surgery access tube, access tube holding handle, hex tightener, retractor blade, light source cable, optic fiber cable.
Instrument system for bipolar hip system
General Hospital/Orthopedics
Class AThe instrument system for bipolar hip system used in surgical procedure includes Advanced Muller Rasp handle for cemented stem, Long scoop for Hip for cemented stem, Rasp for cemented stem, Inserter for cemented stem, Head trail, Tommy bar, Long scoop for Hip for cemented stem, Tommy bar for rasp handle for cemented stem, Trial locating pin for cemented stem, Positioning bar for cemented stem, Head, dismantler for cemented stem, Introducer for cement restrictor, Head trial adaptor, Set of gauges, Ruller for uncemented stem, Rasp handle for uncemented stem, Trial neck for uncemented stem, Rasp for uncemented stem, Repositioning Lever for uncemented stem, Double Curved Gauge for uncemented stem, Proximal Trial Stem for uncemented stem, Gauge for medullary Cavity for uncemented stem, Reduction Lever for uncemented stem, Positioning bar for uncemented stem, Hammer for uncemented stem, Hex wrench for uncemented stem, Distal trial stem for uncemented stem, Proximal trial neck for uncemented stem, Ruller for uncemented stem, Hip head dismenteler for uncemented, Trial adaptor for cemented stem.
Instrument trolley, with/without tray/Mayo Instrument Trolley
General Hospital/Orthopedics
Class ANon-sterile, non-measuringAn open mobile cart intended to store and/or transport instruments for use during surgical and/or medical procedures within a hospital/health care facility.
Insulin Needles/Pen Needles for insulin
General Hospital/Orthopedics
Class BUsed to inject insulin for the treatment of diabetes.
Insulin Syringes
General Hospital/Orthopedics
Class BUsed to inject insulin for the treatment of diabetes.
Internal spinal fixation procedure kit, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA collection of various orthopaedic manual, non- measuring surgical instruments (screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill, etc.) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures) implanted devices are not included. This is a reusable device intended for transient use.
Intervertebral body fusion device
General Hospital/Orthopedics
Class DThe device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion
Intervertebral Body Fusion Device/ Fuse Spinal System
General Hospital/Orthopedics
Class CIt is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels.
Intra Osseous Fixation Wire
General Hospital/Orthopedics
Class CStabilization of fractured bony parts by direct fixation to one another with surgical wires.
Intramedullary fixation rod
General Hospital/Orthopedics
Class CIntended to be implanted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Intramedullary Locking Nail Instrument Sets
General Hospital/Orthopedics
Class BThe Intramedullary locking nail instrument sets includes Awl, Tissue Protector, Nut for coupling bolt, Proximal Jig, Distal Jig, Knob, Proximal Arm for Jig, Coupling bolt, Measuring device, T handle, Universal Spanner, Tommy Bar, Ram, Ram Rod, Jig cover,Detachable Slide Hammer,F-Tool, Spanner Wrench, Standard Tamp, Screw Tightner,Medullary tube Polyamide.
Intramuscular Pressure Monitoring Catheter
General Hospital/Orthopedics
Class BA modified fibre optic transducer-tipped catheter system for measuring intramuscular pressures during exercise.
Intravascular administration set, automated air removal system
General Hospital/Orthopedics
Class BInteded to detect and automatically remove air from an intravascular administration set with minimal to no interruption in the flow of the intravascular fluid.
Intravenous Cannula
General Hospital/Orthopedics
Class BThe IV Cannula is a passive device to provide for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of vascular access devices.
Intravenous hanger
General Hospital/Orthopedics
Class ANon-sterile, non-measuringThe device is intended to be used within the medical application to hold infusion bags within the approved load range.
Isolation gown, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile garment intended to be worn by healthcare providers or visitors to isolate themselves from patients to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor or to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a reusable garment.
Jet lavage
General Hospital/Orthopedics
Class BA jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid.
Joint/spinal manipulator, mechanical, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held, non-electric, mechanically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable device.
Kidney tray/Cidex tray
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA device designed as a receptacle for vomit or oral secretions, typically from an immobile patient (e.g., one confined to bed, chair, or wheelchair). This is a reusable device.
Knee joint femoral (hemi-knee) metallic uncemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace part of a knee joint.
Knee joint femorotibial (uni- compartmental) metal/polymer porous-coated uncemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace part of a knee joint.
Knee joint femorotibial metal/composite non-constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace part of a knee joint
Knee joint femorotibial metal/composite semi-constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace part of a knee joint.
Knee joint femorotibial metal/polymer constrained cemented prosthesis
General Hospital/Orthopedics
Class CKnee joint femorotibial metal/polymer constrained cemented prosthesis.
Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace part of a knee joint.
Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace part of a knee joint.
Knee joint femorotibial metallic constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace part of a knee joint
Knee joint patellar (hemi-knee) metallic resurfacing uncemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace the retropatellar articular surface of the patellofemoral joint
knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis
General Hospital/Orthopedics
Class CIt is intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia.
Knee joint patellofemorotibial metal/polymer prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a knee joint.
Knee joint patellofemorotibial polymer/metal/metal constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a knee joint.
Knee joint patellofemorotibial polymer/metal/pol ymer semi- constrained cemented prosthesis.
General Hospital/Orthopedics
Class CIntended to be implanted to replace a knee joint.
Knee joint tibial (hemi-knee) metallic resurfacing uncemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace part of a knee joint
Knee System Instruments
General Hospital/Orthopedics
Class BThese are surgically invasive instruments which are used manually to assist during total knee arthroplasty. The devices are single use/reusable. The product does not include orthopaedic implants.
Lamb feeding nipple
General Hospital/Orthopedics
Class AA lamb feeding nipple is a device intended for use as a feeding nipple for infants with oral or facial abnormalities
Laminar Air Flow/ Biosafety cabinet (BSL I)
General Hospital/Orthopedics
Class ANon-sterile, non-measuringDesigned as a partial or total enclosure to provide a class I biosafety level (BSL) to the operator and the environment during the manipulation of microorganisms and other biological hazardous materials. Intended for hospital/clinical lab use.
Lifting column with/without control box
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA device in its finished form, specifically designed and intended to control the movement of electric medical beds, examination tables, patient lifts, etc.
Liquid bandage
General Hospital/Orthopedics
Class BPrevention of injection by limiting exposure to dirt and germs in case of minor cuts, abrasions and blisters.
Liquid chemical sterilants/high level disinfectants
General Hospital/Orthopedics
Class CA liquid chemical sterilant/high level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use.
Liquid crystal forehead temperature strip
General Hospital/Orthopedics
Class BA liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes.
Liquid crystal vein locator
General Hospital/Orthopedics
Class ANon-sterile, non-measuringInteded to indicate the location of a vein by revealing variations in the surface temperature of the skin.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Mandibular condyle prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted in the human jaw to replace the mandibular condyle and to articulate within a glenoid fossa.
Mandibular implant facial prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted for use in the functional reconstruction of mandibular deficits.
Manifolds
General Hospital/Orthopedics
Class BIndicated for fluid flow directional control and for providing access port/ports for administration of a solution.
Manual adjustable hospital bed
General Hospital/Orthopedics
Class AA manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed.
Manual general-purpose hospital bed
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. This does not have a therapeutic function.
Manual orthopaedic bender, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manually-operated surgical instrument intended to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. This is not intended for direct on-patient use. This is a reusable device.
Manual orthopedic cement extractor, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to extract orthopaedic (bone) cement from a site of previous application during an orthopaedic surgical procedure to replace a previously cemented prosthesis. This is a reusable device for transient use.
Manual Wheeled stretcher
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual wheeled stretcher is a device intended to transport patients in a horizontal position as an assistance to injury or disability.
Mattress for hospital bed
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be placed over a hospital bed for supporting a patient while resting. Intended for hospital use.
Measured Volume IV Set
General Hospital/Orthopedics
Class BIt is intended for use in the administration of fluids from a container into the patients vascular system through a vascular access device.
Medical bassinet
General Hospital/Orthopedics
Class BIntended for medical purposes in hospital for use (birth to approximately 5 months of age) in a nursery, labor and delivery unit, or patient room.
Medical bowl
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA general-purpose, non-sterile bowl or basin intended for medical purposes such as containing fluids, carrying or holding instruments prior to or during a surgical procedure, and collecting body waste or other matter for disposal. This is a reusable device.
Medical Equipment/instrument drape, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA noninvasive protective barrier intended to cover and protect the equipment/instrument from soiling and/or contamination. This is not a dedicated cap or cover, or a transducer cover. This is reusable.
Medical Equipment/instrument drape, single-use, non-sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA disposable, noninvasive protective barrier intended to cover and protect the equipment/instrument from soiling and/or contamination. This is not a dedicated cap or cover, or a transducer cover.
Medical examination gloves, latex/non latex, non-sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be worn by medical personnel during medical examinations to protect the patient and users from cross infection during examination, check-up, and handling of contaminated medical materials except for surgery.
Medical examination light, AC powered or Battery
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
Medical image printer
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-invasive, reusable printer that produces hard copies of medical video images.
Medical imaging recorder
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-invasive, reusable electrically powered device intended to be used in conjunction with video endoscopes, and/or surgical video imaging devices to digitally record video images.
Medical insole
General Hospital/Orthopedics
Class AIntended for medical purposes that is placed inside a shoe to relieve the symptoms of athlete's foot infection by absorbing moisture.
Medical Instrument cabinet
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to store surgical instruments and equipment in a hospital/health care facility.
Medical instrument cable/lead
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA reusable cable intended for use as a conductor between power source and the medical instrument used for the purpose of transmitting an energy that may, or may not, contain information.
Medical instrument lubricant
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument).
Medical print paper
General Hospital/Orthopedics
Class ANon-sterile, non-measuringThermal, non-gridlined paper intended to be used to produce hard copy of printed data generated by a medical device. For recording the EEG,ECG, EMG output from the ECT device.
Medical washer
General Hospital/Orthopedics
Class BIntended for general medical purposes to clean and dry medical devices, which later undergo sterilization or disinfection before use on patient.
Medical washer-disinfector
General Hospital/Orthopedics
Class BA medical washer-disinfector is a device that is intended for general medical purposes to clean, decontaminate, disinfect, and dry surgical instruments, anesthesia equipment, hollowware, and other medical devices.
Medical/cadaver body bags, non sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for transporting a human corpse without any spread of biohazard/infectious agent.
Medication Injector
General Hospital/Orthopedics
Class BA subcutaneous injection is a method of administering medication.
Medicine cup
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA specially designed cup intended to be used by the nursing staff to administer tablets or pills to patients. It may be used both for tablets and fluids. It does not have measuring function.
Medicine trolley
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to store and transport medications within a hospital/health care facility. This does not include any medications.
Mesh system instruments
General Hospital/Orthopedics
Class AThe instrument used by surgeon include mesh holder, mesh pusher, curved mesh pusher, mesh cutter. The instrument is intended to aid surgeon in placing mesh.(Mesh is not apart of the system.). Mesh is used to provide mechanical support for weakened tissues of the pelvic floor.
Microporous medical tape
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for dressing retention on non-flexing areas and may also be used for patients who have exhibited an adverse reaction to adhesives based upon zinc oxide, rubber, or resin. This is not intended for use as a surgical/wound dressing.
Microporous surgical tape
General Hospital/Orthopedics
Class AIt is intended to secure dressings and for strapping on intact skin.
Moist-cold pressure bandage
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA pressure bandage intended to provide a cool environment and to compress a local area of the body.Intended for intact skin.
Mortuary trolley, mechanical/hydraulic/electric
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA wheeled table or stretcher used to transport a corpse from the morgue's refrigerator to the work area or to transport a corpse from a hospital room to the morgue.
Motorised Wheeled stretcher
General Hospital/Orthopedics
Class BA motorised wheeled stretcher is a device intended to transport patients in a horizontal position as an assistance to injury or disability with a motorised mechanism.
Needle guard
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to encapsulate needles withrawn from vein or fistula thereby aiding in the prevention of needle stick injuries.
Needle Holder
General Hospital/Orthopedics
Class ANeedle holders intended to secure needles during suturing.
Needle/Syringe cutter
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA device intended for use in hospitals and other health care settings to cut a syringe needle to prevent its reuse. This is a reusable device.
Neonatal eye pad
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA neonatal eye pad is an opaque device used to cover and protect the eye of an infant during therapeutic procedures, such as phototherapy.
Neurosurgical Suture Needle
General Hospital/Orthopedics
Class BA needle used in suturing during neurosurgical procedures or in the repair of nervous tissue.
Nipple shield
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman.
Nonpowered flotation therapy mattress
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA nonpowered flotation therapy mattress is a mattress intended for medical purposes which contains air, fluid, or other materials, to treat or prevent decubitus ulcers (bed sores).
OPD Patient couch/chair
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA seat, that may be height-adjustable, intended to be occupied by patients during medical procedures, examinations, or rest it may include support for the back, arms and feet (footrest/ring).
Organ Preservative Solution
General Hospital/Orthopedics
Class CSolution for hypothermic flushing, storage and transport of organs and to maintain the organ vitality during transplant into human recipients.
Orthopaedic bone pin holder
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile device intended to temporarily hold one or more orthopaedic pins (e.g K-Wires) during sterilisation and surgical procedures to prevent damage.
Orthopaedic bone-fragment manipulator, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to help position a fractured fragment of bone to achieve proper alignment (reduction). This is a reusable, non-measuring device intended for transient use.
Orthopaedic bone-reduction tool, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to help reposition a fracture where two sections are out of alignment to achieve reduction for consequent reaming and nailing of the bone. This is a transient-use, reusable device.
Orthopaedic broach, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual surgical instrument intended for shaping and enlarging holes in bone tissue. This is a reusable device.
Orthopaedic chisel blade, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringAn interchangeable component of an orthopaedic chisel that is intended to function as the cutting blade for cutting or contour bone. This is a reusable device for transient use.
Orthopaedic chisel, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to cut and shape bone during orthopaedic surgery. This is a reusable device.
Orthopaedic Countersink
General Hospital/Orthopedics
Class AThe countersinks are bone profilers which are bone- cutting instruments used for bone preparation to enable the placement of gingival part of components during dental procedures in the mouth.
Orthopaedic fixation forceps, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to grasp and manipulate surgical implants/devices (excluding sutures) during implantation it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. This is a reusable device.
Orthopaedic fixation plate tensioner, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to apply tension to an orthopaedic implant (typically a fixation plate) to compress a fracture site prior to final fixation of the implant. This is a reusable device.
Orthopaedic implant driver, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. (implants not included). This is a reusable device intended for transient use.
Orthopaedic implant impactor
General Hospital/Orthopedics
Class AA minimally invasive surgical instrument used in arthroscopy to transmit an impact force on bone and measure the depth of impact.
Orthopaedic implant impactor, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. This is a reusable, non-measuring device.
Orthopaedic implantable- device cutter, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual, hand-held or table-mounted surgical instrument intended to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). This is a reusable device.
Orthopaedic instrument extractor, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to extract another orthopaedic instrument from a patients body during an orthopaedic surgical procedure. This is a reusable device.
Orthopaedic joint/limb rongeur, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to remove bone during an orthopaedic intervention of the limbs/joints it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. This is a reusable device.
Orthopaedic osteotome blade, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. This is a reusable, non-measuring device.
Orthopaedic osteotome, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA chisel-like, manual surgical instrument intended to cut and/or shape bone by percussion during an orthopaedic procedure. This is a reusable, non- measuring device.
Orthopaedic prosthesis implantation positioning instrument, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer- assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide, etc.]. It may be inserted into a bone for a transient duration. This is a reusable device intended for transient use.
Orthopaedic traction bed
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to provide support for skeletal traction to stabilize fracture sites. This does not have a measuring function or diagnostic sensors.
Orthopedic cast padding
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to protect long prominences under the plaster on intact skin .
Orthopedic implant & accessories
General Hospital/Orthopedics
Class CIntended to replace a missing joint or bone or to support a damaged bone.
Orthopedic implantation sleeve, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held, surgical device intended to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not intended to place, angle, and guide a rotating surgical drill. This is a reusable device.
Orthopedic Reamer handle, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held reusable surgical device that is intended to be attached to the proximal end of an orthopaedic reamer shaft to allow the operator to manually rotate the cutting device.
Orthopedic Reamer, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual orthopaedic surgical instrument intended to open and enlarge the medullary canal for the insertion of various devices during prosthesis implantation or fracture fixation procedures. This is a reusable, transient use device.
Orthopedic rod reducer/cutter, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual instrument intended to reduce or seat a rod into the saddle of screws, hooks or similar devices during a surgical procedure. This is a reusable device. This does not include any implantable devices.
Orthopedic Spatula, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held manual surgical instrument intended to spread a material on a surface, to fill material into a cavity, manipulate tissue or to remove a material from a surface or a vessel. This is a reusable device.
Osteotome
General Hospital/Orthopedics
Class AA handheld surgical instrument with a flat cutting edge that can be hit with a hammer used to trim bone. These include box osteotome for uncemented stem & Box osteotomy for cemented stem.
Patient care reverse isolation chamber
General Hospital/Orthopedics
Class BDevice inteded protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality.
Patient enclosure system
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA freestanding, framed, tent-like structure intended to be constructed on-site to function as a temporary enclosure to provide low-stimulation environment for safe playing, resting or sleeping, typically for a patient with autism, epilepsy, challenging behaviours and/or learning difficulties.
Patient examination chair/stool/couch
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA seat, which may be height-adjustable, intended to be occupied by patients during medical procedures, examinations, or rest it may include support for the back, arms and feet (footrest/ring). Intended for hospital use.
Patient isolation tent canopy
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile covering intended to be used with a frame to provide environmental isolation of a contagious patient to protect hospital personnel and other patients from exposure to non-airborne infections (e.g. diphtheria, meningococcus) whilst the patient is being treated.
Patient lift, Electrcially powered
General Hospital/Orthopedics
Class BInteded to lift and transport patients in hsoptial in the horizontal or other required position from one place to another, as from a bed to a bath.
Patient scale
General Hospital/Orthopedics
Class AA patient scale is a device intended for medical purposes that is used to measure the weight of a patient who cannot stand on a scaleby placing scale under a bed or chair to weigh both the support and the patient.
Pediatric medical crib
General Hospital/Orthopedics
Class BIntended for medical purposes for use with a pediatric patient.
Pedical Screw Instruments
General Hospital/Orthopedics
Class AThe instruments include rocker, Tap breaker, Persuader, Sound, Quick Change. These instruments used tio aid surgeon in placing pedical screw in spinal fusion surgery.
Pedicle screw spinal system
General Hospital/Orthopedics
Class CIt is intended to provide immobilization and stabilization of spinal segments.
Periostic elevator
General Hospital/Orthopedics
Class AA sterile, single use dental instrument shaped as a kind of a lever designed to lift, separate, or displace teeth &/or soft tissues during dental procedures.
Plaster instruments/plaster saw
General Hospital/Orthopedics
Class ANon-sterile, non-measuringAn instrument intended to cut or shave or put plaster.
Plaster Instruments/Saw
General Hospital/Orthopedics
Class AA instrument used to cut or shave or put plaster. The instruments include plaster sawengle type & heavy duty type, plaster bender, plaster spreader, plaster shear.
Plaster Knife
General Hospital/Orthopedics
Class AA flat-bladed instrument with a cutting edge used to cut or shave plaster.
Plaster of Paris Bandage
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended for support of fractured body part.
Plaster spreader
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to separate and spread hardened plaster.
Plaster Spreader – Modified & Hanning Type
General Hospital/Orthopedics
Class AA manual surgical instrument with specially designed blades used to separate and spread hardened plaster, i.e., that which has already been used to form a cast.
Plates, Clippers, Screws
General Hospital/Orthopedics
Class Crigid, limb brace, lumbar, lumbo-sacral, rib fracture, sacroiliac, thoracic oethosis.
Pliers
General Hospital/Orthopedics
Class AThe purpose of these instruments is to hold, bend or cut commonly used orthodontic materials such as wires. These include Wire bending pliers, Cerclip plier & locking plier.
Pneumatic Tourniquet & its attachment
General Hospital/Orthopedics
Class AThe tourniquet used for stopping flow of blood through artery by compression. The attachment includes Consol unit & cuffs.
Portable system mount
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be fixed vertically within a clinical setting to enable the easy and secure mounting of a portable medical device.
Prefillable Glass Barrel with needle
General Hospital/Orthopedics
Class BIntended for the automatic self- administration of drugs and biologics from standard Glass Barrel.
Pressure infusor for an I.V. bag
General Hospital/Orthopedics
Class BDevice inteded to inflate and increases the pressure on the I.V. bag to assist the infusion of the fluid
Professional examination gown, non-sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be worn by healthcare providers, sometimes over scrub suits, while examining patients to protect both the patient and staff from the transfer of contaminants such as microorganisms or body fluids. This is a reusable device.
Psychiatric physical restraint
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for use in psychiatric wards and other hospital environments to secure patient to chair, wheelchair, bed etc. to prevent self-harm or injuries to the health care professional handling the patient.
Pusher
General Hospital/Orthopedics
Class AA hand-held dental instrument designed for positioning & adapting metal bands on teeth in orthodontics.
Rail Fixation System
General Hospital/Orthopedics
Class BThe Rail Fixation System consists of series of external fixators intended to be used to stabilize bone segment in a broad range of indications,including fractures, joint fusion, bone transport, lengthening & angular corrections. The system contains rail, Sandwich Plate, Dyna Ring, Bolt For Sandwich Plate, compression-distraction Unit.
Re use Prevention (RUP) syringes for therapeutic injections (Syringes with re-use prevention feature)
General Hospital/Orthopedics
Class BIntend to inject fluids into or withdraw fluids from the body.
Reamer & its attachment
General Hospital/Orthopedics
Class AA hand hold instrument used to enlarge. It includes pedicle reamer, reamer for cemented stem, Distal reamer for uncemented stem, adaptors for reamers & Quick Change. The product does not include orthopaedic implants.
Remote Medication Management System
General Hospital/Orthopedics
Class BThe system is intended to store the patients prescribed medications in a delivery unit, to permit a health care professional to remotely schedule the patients prescribed medications, to notify the patient when the prescribed medications are due to be taken, to release the prescribed medications to a tray of the delivery unit accessible to the patient on the patients command, and to record a history of the event for the health care professional.
Rescue blanket/ Emergency Heat loss prevention blanket
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-powered device intended to keep a person warm and/or to prevent the further loss of body heat in emergency/rescue situations.
Resorbable calcium salt bone void filler device
General Hospital/Orthopedics
Class CA resorbable calcium saltbone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis
Retractor
General Hospital/Orthopedics
Class AHandheld surgical device used to hold soft tissues retracted from the field of view. These include Self- Retaining Retractor,
Retractor Holder
General Hospital/Orthopedics
Class AA mechanism to which surgical retractors are mounted to, in order for the retractors to hold back tissues.
Retractor, orthopaedic, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA hand-held, manual surgical instrument intended to be used to separate and/or draw back, or separate, tissues to permit access to skeletal structures for examination or intervention. This is a reusable device intended for transient use.
Rod Cutter/Reducer
General Hospital/Orthopedics
Class AA reusable surgical instrument used to reduce or seat an implantable rod into the saddle of the implant.
Sacculotomy tack (Cody tack)
General Hospital/Orthopedics
Class CIntended to be implanted to relieve the symptoms of vertigo.
Sacroiliac joint fixation
General Hospital/Orthopedics
Class CThe sacroiliac joints fixation may serve as protective mechanism for the lumbosacral region.
Scissor
General Hospital/Orthopedics
Class AIntended to used for cutting various materials, i.e. gauze.
Scissors, orthopaedic, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual, hand-held surgical instrument intended to cut bone or cartilage tissue during orthopaedic surgery. This is a reusable device for transient use.
Scoop stretcher
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to transfer a trauma patient and reduce the chance of undesirable movement of injured areas.
Screw-extraction orthopedic reamer, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA surgical tool intended for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. This is a reusable device. This does not have a measuring function.
Shaver System
General Hospital/Orthopedics
Class BSurgical device intended for the resection of soft and osseous tissues during a surgical procedure.
Shoulder joint glenoid (hemi- shoulder) metallic cemented prosthesis
General Hospital/Orthopedics
Class CIt is intended to be implanted to replace part of a shoulder joint
Shoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis
General Hospital/Orthopedics
Class CA shoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis.
Shoulder joint metal/metal or metal/polymer constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a shoulder joint
shoulder joint metal/polymer non-constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a shoulder joint
Shoulder joint metal/polymer semi-constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a shoulder joint
Shoulder joint metal/polymer/met al nonconstrained or semi-constrained porous-coated uncemented prosthesis
General Hospital/Orthopedics
Class CIt is a device intended to be implanted to replace a shoulder joint
Single Lumen Hypodermic Needle
General Hospital/Orthopedics
Class BA hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Six axis correction apparatus with software
General Hospital/Orthopedics
Class BThe software along with apparatus used to correct multi plane deformity or bone fracture. The system include struts, C/Y plate connector, Labels for strut, clamps, rings, wires & screws.
Skin abrasion file/ Podiatric bur, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be used by a podiatrist for debridement of thickened nails and callus.
Skin adhesive protective material
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to protect healthy skin from friction during removal of tapes and films. It provides a thin protective layer on the skin and helps tape and film adhesion.
Skin pressure protectors
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA skin pressure protector is a device intended to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patients developing decubitus ulcers (bedsores)
Skin traction kit
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to provide traction for fractured femur.
Skin-cover sealant/Synthetic polymer liquid barrier cream
General Hospital/Orthopedics
Class ANon-sterile, non-measuringThis is a non-cytotoxic liquid skin barrier film for intact skin only intended to form a transparent flexible film to prevent skin irritation caused by moisture e.g. urine, friction from bedding or by adhesive products, etc. Intended for intact skin. This does not contain pharmaceuticals and not intended for use on wounds or for any therapeutic purposes.
Sleeves and its attachment
General Hospital/Orthopedics
Class AManual surgical instruments that aid in the placement of bone cuts when preparing site to accept the implant components. These include Sleeve for Block for Half Pin, locking sleeve.
Smooth or threaded metallic bone fixation fastener
General Hospital/Orthopedics
Class CIt may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Snoring sensor
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for use in the detection of snoring, muscle movement, respiratory effort and/or airflow. It does not have a measuring function.
Special bevelled needles for implantable vascular access system
General Hospital/Orthopedics
Class CPower - injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. It is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the needle is also indicated for power injection of contrast media.
Spinal cage system instruments
General Hospital/Orthopedics
Class AThe spinal cage system instruments are used by surgeon for spinal implants, devices or hardware, uses surgical procedures to implant titanium, titanium- alloy, stainless steel, or non-metallic devices into the spine. The instrument set includes rasp for cervical disc spacer, bone graft compactor, bone tamp for cervical disc spacer, cage support block, cervical distractor pin, cutter for cage, funnel, graft, seat holder for cervical disc spacer, introducer for cervical disc spacer, left angled curette, quick change, quick change for box chisel, spreader, tap handle - quick coupling, threaded inserter for droner peek cage, tlif cage guide, tlif cage holder, tommy bar for cages, trial for droner peek/plif /radial tlif cage, Cervical Distractor, Rasp For Radial Tlif/Plif Cage, Right Angled Curette, Screw Tighter, Pin Introducer For Vertebral Distractor, Plif Cage Holder, Dura, Curette. The system does not include orthopaedic implants.
Spinal fluid manometer
General Hospital/Orthopedics
Class BA spinal fluid manometer is a device used to measure spinal fluid pressure using needle and graduated column.
Spinal Instrument
General Hospital/Orthopedics
Class AThe instruments used in spinal surgery. These include Bone Cutter, Bone Nibbler Single / Double Action, Bone Nibbler Single Action, Hijack Punch, Disc Punch, Chisel with Detachable Handle Gouge with fiber handle, Plate holding forcep for C1-C2 spacer, Rounger Right Angle, Sargent Rounger, Rounger Kiliner, Olecrona Rounger, Lacksell Rounger, Kerrison Punch, Rib Rasperactory, Mastroid Retractor, Kochar's Bone hook, Micro cob elevator, Elevator Cobs, Chisel with attached fiber handle, Bone Lever, Micro Curettes, Meatal Curette, Curette, Gauge, Atraumatic Micro Force, Plate holding forcep for C1-C2 spacer, Introducer for C1- C2 spacer.
Spinal interlaminal fixation orthosis
General Hospital/Orthopedics
Class CA device intended to be implanted made of an alloy, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is used primarily in the treatment of scoliosis
Spinal intervertebral body fixation orthosis
General Hospital/Orthopedics
Class CThe device is used to apply force to a series of vertebrae to correct "sway back," scoliosis (lateral curvature of the spine), or other conditions.
Stand-on patient scale
General Hospital/Orthopedics
Class AIntended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.
Stationary patient lift, electric
General Hospital/Orthopedics
Class ANon-sterile, non-measuringAn electrically-powered, fixed assembly of devices intended to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist.
Stationary patient lift, manual
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-powered, fixed assembly of devices intended to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort within an area limited by the lifting radius of the system. Also known as a patient hoist.
Steam sterilizer
General Hospital/Orthopedics
Class CA steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical devices by means of pressurized steam.
Sterilization container
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA device intended to contain medical instruments during sterilization. This is a reusable device.
Sterilization process indicator (Biological)
General Hospital/Orthopedics
Class BA biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization on medical device.
Sterilization process indicator (Physical/chemical)
General Hospital/Orthopedics
Class BA physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process on medical device.
Sterilization wrap
General Hospital/Orthopedics
Class BIt is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Sterilization/disinfection containers
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector (not included) and/or sterilizer (not included) during the washing/disinfection and/or sterilization cycle(s).
Sterilizer/disinfector rack
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile rack intended to hold medical devices in a steriliser or chemical washer/disinfector (not included) during the sterilisation or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their storage. This is a reusable device.
Sternal fixation Reconstructive implant
General Hospital/Orthopedics
Class CSternal Fixation System is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.
Suction snakebite kit
General Hospital/Orthopedics
Class AIntended for removing venom from the wound.
Surgical brassiere
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to be used as a compression device after breast surgery to prevent the formation of oedema and to support venous return and lymphatic drainage. It does not contain pharmaceutical agents.
Surgical clip rack, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA device typically intended to be used as a container to hold and protect implantable clips (not included) during the sterilization process. This is a reusable device.
Surgical Dressings
General Hospital/Orthopedics
Class ADressing aerosol, non-adherent, dressing, periodontal, kit, dressing pad, dressing.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Surgical Dressings
General Hospital/Orthopedics
Class BDressing-gel, dressing- permeable, moisture dressing, tracheostomy tube dressing, wound and burn dressings, hydrogel dressing, wound and burn, occlusive.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Surgical Dressings
General Hospital/Orthopedics
Class CMaterial dressing, surgical, polylactic acid dressings.
CDSCO lists this name more than once with different classes. Match on the intended use and category.
Surgical Drill & its attachment
General Hospital/Orthopedics
Class BThe surgical drilling machine that, when rotated at an appropriate speed, will cut into bone creating a hole of the same dimension as the diameter of the bit. The attachment includes drill bit, drill guides, burr & handpiece.
Surgical drill guide, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA manual surgical device intended to simultaneously place, angle, and guide a surgical drill on hard tissue (e.g., bone). This is a non- measuring, reusable device intended for transient use.
Surgical Elevator
General Hospital/Orthopedics
Class AA Handheld Surgical Instrument that is a long flat piece of metal, with a blunt end and an optional hook end, used to lift organs or tissues with lifting force normally supplied by an assistant.
Surgical Mallet
General Hospital/Orthopedics
Class AA hand held surgical instrument that is used by a surgeon to manually impart a force on another device during surgical intervention.
Surgical Probe
General Hospital/Orthopedics
Class AIt includes curved/straight probe, thorasic probe, Depuy Probe Curved.
Surgical Punch/Bone Punch
General Hospital/Orthopedics
Class AA surgical instrument used to punch holes in bone, typically for the purposes of biopsy procedures or for fixation procedures. The instrument can be ring handled, pistol grip or shaft-like in design. Ring handled or pistol grip designs feature extended shafts which terminate in a punch-like or mechanical jaw mechanism at the distal tip. The shaft-like instrument is a hollow tube, sharpened on one end, and is usually used with a trocar.
Surgical Screw Driver
General Hospital/Orthopedics
Class AA metal instrument designed to impart force on another instrument. The distal end is shaped to mate with the instrument being driven into some form of tissue. The proximal end is designed to absorb & transmit an impact force.
Surgical Spatula
General Hospital/Orthopedics
Class AIt is reuseable surgical instrument designed to rotate and /or dissect tissues, bone fragments & other instruments.
Surgical Trays
General Hospital/Orthopedics
Class ANon-sterile, non-measuringTrays are containers intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure. They might in addition be used during reprocessing/sterilization procedures. They are non- invasive, reusable devices.
Suture Absorable
General Hospital/Orthopedics
Class CThe device is intended for use in general soft tissue approximation and ligation.
Suture Non Absorable Synthetic
General Hospital/Orthopedics
Class CNon-absorbable suture is comprised of surgical steel as well as synthetic non- absorbable sutures for use in general soft tissue approximation and ligation.
Tamp, Surgical
General Hospital/Orthopedics
Class AInserted into the disc space to pack and fill the disc space with bone graft/bone substitute at the end of surgery. End of shaft is normally impacted with a mallet supplied by the hospital to further pack the bone into the disc space. Not an implantable device.
Tearable adhesive plaster
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to secure dressings and for strapping on intact skin.
Tearable Adhesive Tape
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIt is intended to secure dressings and for strapping on intact skin.
Templates
General Hospital/Orthopedics
Class AA single use, sterile surgical instrument intended to be used to correctly position an implant. It can be used before making the incision to mark the implant shape, after making the incision, to check the implant position and during the coil pocket creation to check for its size. The product does not include orthopaedic implants.
Therapeutic medical binder
General Hospital/Orthopedics
Class AIntended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place like abdominal, breast and perineal binder.
Therapeutic scrotal support
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for medical purposes to support the scrotum (the sac that contains the testicles)
Thick /Thin Guide Pin
General Hospital/Orthopedics
Class AThe guide pin is to be used facilitate precise placement of a cannulated screw during orthopaedic surgery.
Thick /Thin Guide Pin, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile instrument intended to be used to facilitate precise placement of a cannulated screw during orthopaedic surgery. This is a reusable, non-measuring device intended for transient use.
Toe joint phalangeal (hemi- toe) polymer prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace the base of the proximal phalanx of the toe.
Toe joint polymer constrained prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace the first metatarsophalangeal (big toe) joint
Torque Wrench
General Hospital/Orthopedics
Class AThe torque wrench is used to tighten the setscrew on the connector assemblies of the implantable pulse generator and extension.
Total temporomandibular joint prosthesis
General Hospital/Orthopedics
Class DIntended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.
Traditional single use syringe without safety feature (Sterile hypodermic syringes for single use)
General Hospital/Orthopedics
Class BIntend to inject fluids into or withdraw fluids from the body.
Transfusion or Perfusion sets for single use
General Hospital/Orthopedics
Class BTransfusion Set is used to administer blood/drugs to a patients vascular system through a needle or catheter inserted into a vein.
Trocars
General Hospital/Orthopedics
Class BA trocar is made up of an obturator (which may be a metal or plastic sharpened or non-bladed tip), a cannula(basically a hollow tube), and a seal. The trocar functions as a portal for the subsequent placement of other instruments, such as graspers, scissors, staplers, etc. It is also intended to remove air or fluid for the pleural space in a closed, one way fashion.
Ultrasonic cleaner for medical instruments
General Hospital/Orthopedics
Class BIntended for cleaning medical instruments by the emission of high frequency soundwaves
Ultraviolet (UV) radiation chamber disinfection device.
General Hospital/Orthopedics
Class CAn ultraviolet (UV) radiation chamber disinfection device is intended for the low-level surface disinfection of non-porous medical device surfaces by close-controlled UV irradiation.
Ultraviolet (UV) radiation environmental disinfection device
General Hospital/Orthopedics
Class BA medical ultraviolet air purifier is a device intended for medical purposes in hospital/clinic to destroy bacteria in the air by exposure to ultraviolet radiation.
Unilateral External Fixation System
General Hospital/Orthopedics
Class BA collection of instruments used for the placement of external fixation system into or onto bone that may involve external fixation. The instruments include Rods for holding clamps, Spanners, Compressors, Spanners, Screw Guide.
Vacuum-powered body fluid suction apparatus
General Hospital/Orthopedics
Class BA vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids.
Vial Adapter
General Hospital/Orthopedics
Class BIt is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial.
Vice Grip
General Hospital/Orthopedics
Class AThe product used to hold pliers.
Visitor hygiene coverall
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA garment intended to be worn over existing clothing by a visitor, or staff, in a healthcare facility when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. This is a single-use device.
Visualization system for arthroscopic and endoscopic procedure
General Hospital/Orthopedics
Class AThey are used in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of surgical sites.
Waiting area chair
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended for use in hospitals/health care settings for supporting patients and their next of kin while waiting for a medical examination/treatment.
Wash basin stand
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be used in a hospital environment to support a wash basin used for the thorough cleaning/scrubbing of the hands, fingernails, and arms of health care personnel before surgery or other procedures that require a high level of hygiene.
Washers for body waste receptacles
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA washer for body waste receptacles is a device intended for medical purposes that is used to clean and sanitize a body waste receptacle, such as a bedpan.
Wire tensioner
General Hospital/Orthopedics
Class AAn orthopaedic, manual hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a wire that is being implanted, usually as part of a system to provide corrective surgery to the spine. The product does not include orthopaedic implants.
Wire tensioner, reusable
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be used during orthopaedic surgery to apply an appropriate tension to a wire that is being implanted. This is a non-measuring, reusable device.
Wound Closure Device
General Hospital/Orthopedics
Class BWound Closure Devices are indicated for soft tissue approximation.
Wound Dressings/Bacteriostatic Wound Dressings
General Hospital/Orthopedics
Class CIncludes Beads, Hydrophilics For Wound Exudate Absorption for wound care.
Woven gauze pad, non- sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-medicated, non-sterile device in the form of a patch or swab (also referred to as a sponge) intended to absorb fluids from superficial wounds or abrasions. This may also be used to apply topical medication.
Woven gauze roll, non-sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically intended for a variety of applications (non- dedicated) such as a primary wound dressing (superficial wounds), dressing retention, injury padding and compression.
Woven gauze sheet, non- sterile
General Hospital/Orthopedics
Class ANon-sterile, non-measuringA non-sterile device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose) intended for a variety of applications (non-dedicated) such as a primary superficial wound dressing, dressing retention, and injury padding and compression.
Wrench
General Hospital/Orthopedics
Class AA heavy-duty, surgical instrument with specially designed sturdy handles and gripping jaws (typically parallel) used to grip and hold an object during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically broad with serrations) at the working end are activated through a single pivot or a double ratio- lever exchange pivot to provide greater gripping force. This is a reusable device. This include combination wrench.
Wrist joint carpal lunate polymer prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace the carpal lunate bone of the wrist.
Wrist joint carpal scaphoid polymer prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace the carpal scaphoid bone of the wrist.
Wrist joint carpal trapezium polymer prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace the carpal trapezium bone of the wrist
Wrist joint metal constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a wrist joint
Wrist joint metal/polymer semi-constrained cemented prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a wrist joint.
Wrist joint polymer constrained prosthesis
General Hospital/Orthopedics
Class CIntended to be implanted to replace a wrist joint
X- ray marker for strut
General Hospital/Orthopedics
Class ANon-sterile, non-measuringIntended to be used in Six axis correction apparatus with software.
Y-Connector as an accessory to perfusion sets
General Hospital/Orthopedics
Class AIt can be used to connect to a perfusion sets or catheter for infusion of contrast media etc.
Data from CDSCO's online system for medical devices, retrieved 2026-10-31.
Sources
- Risk Classification Approved Device Details, CDSCO online system for medical devices. Retrieved 31 October 2026.
- Merged existing medical devices risk classification, CDSCO public notice, 1 January 2025.
See the full source list and how the data is compiled on the main classification page. This is a reference aid, not legal or regulatory advice.
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