Intended Use<\/strong> <\/td><\/tr>| 1 <\/td> | Abdominal support\/belt\/binders, reusable <\/td> | Intended to hold abdominal muscles together to relieve pain and increase circulation at the surgical site to promote healing and decrease swelling. May also make physical activity more comfortable. <\/td><\/tr> |
| 2 <\/td> | Abdominal\/ENT\/orthopaedic surgical probe, reusable <\/td> | A 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. <\/td><\/tr> |
| <\/td> | <\/td> | <\/td><\/tr> |
| 3 <\/td> | Absorbent Underpad, non-antimicrobial <\/td> | A 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. <\/td><\/tr> |
| 4 <\/td> | Adaptor, non-sterile <\/td> | Non-invasive adapters which connect or stopper enteral feeding tubes. <\/td><\/tr> |
| 5 <\/td> | Alcohol swab <\/td> | A non-sterile absorbent swab containing alcohol intended for cleaning and scrubbing of needle access sites. <\/td><\/tr> |
| 6 <\/td> | Alternating-pressure bed mattress overlay, reusable <\/td> | A 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. <\/td><\/tr> |
| 7 <\/td> | Alternating-pressure bed mattress overlay, single-use <\/td> | A 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, patients with disabilities, or patients with low body fat. <\/td><\/tr> |
| 8 <\/td> | Anaesthesia catheter Luer connector, non-sterile <\/td> | Intended to create a mechanical union between an anesthesia catheter and an external device. <\/td><\/tr> |
| <\/td> | <\/td> | <\/td><\/tr> |
| 9 <\/td> | Anaesthesia tube holder, non-sterile <\/td> | The intended purpose for this device is for holding and supporting respiration tubing and breathing circuits connected to a patient to prevent disconnection. This is a noninvasive device. <\/td><\/tr> |
| 10 <\/td> | Alignment guide for orthopedic fixation <\/td> | A reusable instrument intended to facilitate the correct orientation (alignment) of an implant during a surgical procedure. This is a non-measuring device intended for transient use. <\/td><\/tr> |
| 11 <\/td> | Bath towelette <\/td> | A 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. <\/td><\/tr> |
| 12 <\/td> | Bedside screen <\/td> | General-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). <\/td><\/tr> |
| 13 <\/td> | Biohazard spill clean-up kit <\/td> | A 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. <\/td><\/tr> |
| <\/td> | <\/td> | <\/td><\/tr> |
| 14 <\/td> | Bite block, endoscopy, non-sterile <\/td> | A reusable device intended to be inserted in a patient’s mouth to maintain oral patency and protect both the patient and the endoscope (not included) when an endoscope is inserted into a patient’s mouth for a procedure. It does not have any additional functionality. <\/td><\/tr> |
| 15 <\/td> | Breast binder <\/td> | A non-sterile device intended to be applied to the breast or breasts for soft tissue support or securing a dressing in place after surgical procedures. <\/td><\/tr> |
| 16 <\/td> | Breast pump support kit, reusable <\/td> | A collection of non-sterile items (e.g., breast shields, tubing, connectors, milk collection containers, etc.) intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and\/or feeding an infant. This is a reusable device. <\/td><\/tr> |
| 17 <\/td> | Capnography sampling adaptor <\/td> | It is a non-sterile device intended to function as an interface between an in situ airway device (e.g., oropharyngeal airway, face mask, nasal oxygen cannula) and respiratory sampling tubing connected to a carbon dioxide monitor (capnograph). <\/td><\/tr> |
| 18 <\/td> | Cardiopulmonary resuscitation mouthpiece\/cover <\/td> | A non-sterile device that consists of a mouthpiece with an integrated face\/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (CPR) to prevent cross-contamination between patient and CPR administrator. This is a single-use device. <\/td><\/tr> |
| 19 <\/td> | Chemotherapy spill clean-up kit, non-sterile <\/td> | Intended to safely clean and dispose of Chemotherapy drug spills. All components are supplied non-sterile. <\/td><\/tr> |
| 20 <\/td> | Conductive abrasive gel for skin preparation, non-sterile <\/td> | Non-sterile conductive gel intended to reduce the resistance (impedance) and defatting the skin in preparation for electrophysiological examinations: electroencephalography (EEG), long-term EEG monitoring, polysomnography (PSG), evoked potentials (EP), stress test ECG, ECG monitoring by Holter in clinics, hospitals, diagnostic centers. <\/td><\/tr> |
| 21 <\/td> | Conductive electrode gel\/paste (adhesive\/non-adhesive), non-sterile <\/td> | A non-sterile gel intended to reduce resistance between skin and electrodes during examinations such as ECG, EEG, EMG, etc. <\/td><\/tr> |
| 22 <\/td> | Contact lens inserter\/remover, non-sterile <\/td> | Intended to insert and remove contact lenses from the eye. It does not come in direct contact with the eyeball. This is a reusable device. <\/td><\/tr> |
| 23 <\/td> | CPAP\/BPAP chin strap, single use <\/td> | A non-sterile, disposable device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during positive airway pressure (PAP) therapy to control mouth air leaks by gently holding the mouth closed. <\/td><\/tr> |
| 24 <\/td> | Dental impression material kit, single-use <\/td> | A collection of non-sterile devices intended to obtain a negative imprint of the teeth. The kit typically includes dental impression materials and a dental impression tray(s). <\/td><\/tr> |
| 25 <\/td> | Dental material mixing nozzle, non-sterile <\/td> | A device intended for mixing inactive compounds during a dental procedure to produce a functional dental restorative\/impression material (not included) which may be applied directly to the oral cavity\/teeth of the patient or used for some other dental application. <\/td><\/tr> |
| 26 <\/td> | Dental matrix band, single-use, non-sterile <\/td> | A dental instrument intended to contour a dental restorative material to match dentition within the oral cavity. This is a non-sterile, single-use device. This is not a dental implant. <\/td><\/tr> |
| 27 <\/td> | Dental rubber dam, non-sterile <\/td> | A non-sterile dental device intended to be placed over the teeth during dental procedures for uses such as 1) to isolate the field of operation from the rest of the oral cavity, 2) to eliminate saliva, 3) to prevent the patient swallowing liquid\/dental material, 4) to protect soft tissue from harmful solutions, and 5) to reduce risk of infection. <\/td><\/tr> |
| 28 <\/td> | Douche kit <\/td> | A packaged collection of non-sterile items (douche solution prefilled in a douche unit) intended to provide cleansing of the vaginal area. <\/td><\/tr> |
| 29 <\/td> | Ear Irrigation kit <\/td> | A collection of non-sterile items intended to irrigate the ear canal with solution to clear wax and debris. It may consist of curette, forceps, a manually-operated flushing device (e.g., spray bottle, syringe, etc.) and accessory items (e.g., a cup to collect used irrigation solution). This is a reusable device. <\/td><\/tr> |
| 30 <\/td> | Enema tube, non-sterile <\/td> | A non-sterile length of tubing that is used as a conduit between the enema bag and the enema tip for the delivery of the enema solution into the rectum. <\/td><\/tr> |
| 31 <\/td> | ENT illuminating foreign body extraction set <\/td> | A collection of devices which includes a foreign body extraction instrument (typically a curette or forceps), and an electrically-powered light source, and a magnifying lens intended to be inserted into the nasal or ear canal to grip and extract a foreign body\/debris (e.g., ear wax) during an ear\/nose\/throat (ENT) procedure, it is not intended for surgical grasping or manipulation of tissues. It is supplied non-sterile and is non-measuring. <\/td><\/tr> |
| 32 <\/td> | Enteral feeding\/decompression tube clearing stem <\/td> | A non-sterile, sheath-covered device intended to be used to mechanically clear a clog in an in situ nasogastric, nasoenteral, gastrostomy and\/or jejunostomy tube, used for feeding and\/or decompression, to maintain luminal patency. <\/td><\/tr> |
| 33 <\/td> | Eye cup <\/td> | A cup-shaped device, supplied non-sterile. intended to fit around the eye socket and placed over the eye to allow washing of the affected eye. <\/td><\/tr> |
| 34 <\/td> | Eye heat therapy mask, self-heating, single-use <\/td> | A non-sterile, self-heating device intended for delivering moist heat to the eyes for relief in dry eyes syndrome, fatigue, soreness, meibomian gland function, etc. <\/td><\/tr> |
| 35 <\/td> | Female wearable urinal, reusable <\/td> | A non-sterile, external urine drainage device intended for women specially formed to securely fit around the female genitals for urinary incontinence management by providing a route to channel urine, via a tube, into a collection bag. <\/td><\/tr> |
| 36 <\/td> | Finger protector, non-sterile <\/td> | A 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. <\/td><\/tr> |
| 37 <\/td> | Gastrointestinal ostomy tube pocket <\/td> | A non-sterile, noninvasive pouch intended to be wrapped around the protruding end of a gastrointestinal ostomy tube (e.g., gastrostomy or jejunostomy tube) to hold and support it in order to ensure its stabilization on the patient. <\/td><\/tr> |
| 39 <\/td> | Gravity enema set, non-sterile <\/td> | A set of non-sterile device intended to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. <\/td><\/tr> |
| 40 <\/td> | Handgrip cover for surgical light <\/td> | Intended to provide physical barrier on a handgrip to prevent cross-contamination between the operating room surgical lights (non-sterile) and the operating room personnel. <\/td><\/tr> |
| 41 <\/td> | Hydrophilic wound dressing, non-sterile <\/td> | A non-sterile device intended to cover a superficial wound and to absorb exudate. <\/td><\/tr> |
| 42 <\/td> | Infant limb immobilizer, reusable <\/td> | A non-sterile device intended to temporarily render parts of an infant’s body immovable, e.g. the arms and\/or feet while the patient undergoes therapeutic or diagnostic interventions. <\/td><\/tr> |
| 43 <\/td> | Inguinal hernia belt (Adult)\/surgical truss, singe use <\/td> | A single use, non-sterile device intended to relieve discomfort and hernia pain caused by an inguinal or sports hernia. <\/td><\/tr> |
| 44 <\/td> | Intestinal stoma shield\/support belt <\/td> | A non-sterile plate intended to be placed over an enteric stoma to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. <\/td><\/tr> |
| 45 <\/td> | General internal orthopaedic fixation system implantation. kit, reusable, non-measuring <\/td> | A 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. <\/td><\/tr> |
| 46 <\/td> | External limb prosthetic component <\/td> | A non-measuring, non-active device intended for medical purposes that, when put together with other appropriate components, constitutes a total prosthesis (non-active), e.g., socket components, suction valves, etc. <\/td><\/tr> |
| 47 <\/td> | Euthyscope <\/td> | A hand-held device intended to project a bright light encompassing an arc of approximately 30 degrees on the fundus of the eye for the treatment of amblyopia. This is a non-measuring, reusable device. <\/td><\/tr> |
| 48 <\/td> | ENT illuminating foreign body extraction set <\/td> | A collection of devices which includes a foreign body extraction instrument (typically a curette or forceps), and an electrically-powered light source, and a magnifying lens intended to be inserted into the nasal or ear canal to grip and extract a foreign body\/debris (e.g., ear wax) during an ear\/nose\/throat (ENT) procedure, it is not intended for surgical grasping or manipulation of tissues. It is supplied non-sterile and is non-measuring. <\/td><\/tr> |
| 49 <\/td> | Driver\/extractor, reusable <\/td> | A hand-held, manually-operated, combination surgical instrument intended to be used in the insertion and\/or removal of, e.g., a pin, screw or appliance during surgical procedures. This is a reusable; non-measuring device intended for transient use. <\/td><\/tr> |
| 50 <\/td> | Dental surgical probe, reusable <\/td> | A hand-held manual dental surgical instrument intended to be used to explore and\/or perform therapeutic procedures during various types of dental surgical intervention. This is a non-measuring, reusable device. <\/td><\/tr> |
| 51 <\/td> | Circumcision kit, reusable <\/td> | A collection of various non-sterile, non-powered, reusable instruments, dressings, etc. intended to perform a circumcision procedure. Typical components include circumcision clamp, scissors, and scalpel. This is a non-measuring. reusable device and does not contain pharmaceuticals. <\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n |