Profile: Tyco Healthcare UK Ltd. is a manufacturer and distributor of medical devices. Our products include disposable medical supplies, monitoring equipment, medical instruments and bulk analgesic pharmaceuticals. We provide a wide range of disposable and washable products to help manage incontinence. We offer a wide range of colored garments for discharged hospital patients who require continued DVT prevention. Through prescription, our Lastosheer range prevents leg swelling associated with varicose veins or leg ulcerations. The Lastosheer range of graduated compression hosiery is designed to help prevent the spread of varicose veins by helping the body’s own circulation system. They are available in three different compression strengths and in a range of fashion colors. There are also stockings, tights and socks to suit everyone’s needs. We offer a comprehensive range of products for all aspects of critical care. Our Goodknight range of CPAP devices are small and lightweight. They are easy to set up and are useful for both patients & physicians. Our range of CPAP devices give the physician a comprehensive tool to treat patients. Hypnott is our portable multi-channel recording system for sleep related breathing disorder diagnosis, from adult through infant. It is designed to record up to 11 channels for up to 24 hours (12 hours with ECG).
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• Automatic Surgical Stapler (FDA Code: GAG / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• Cardiovascular Suture (FDA Code: DTH) |
• Clip Surgical Applier (FDA Code: GDO / 878.4800) |
• Colostomy Rod (FDA Code: EZP / 876.4270) A colostomy rod is a device used during the loop colostomy procedure. A loop of colon is surgically brought out through the abdominal wall and the stiff colostomy rod is placed through the loop temporarily to keep the colon from slipping back through the surgical opening. |
• Disposable Suture Needle (FDA Code: GAB / 878.4800) |
• Enteral Irrigation Kit w/Piston Syringe |
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800) |
• Implantable Clip (FDA Code: FZP / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable. |
• Ligature Carrier (FDA Code: GEJ / 878.4800) |
• Ligature Carrier Set (FDA Code: GEJ / 878.4800) |
• Monofilament & Multifilament Steel Non-Absorbable Suture (FDA Code: GAQ / 878.4495) A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure. |
• Monofilament Synthetic Absorbable Sutures |
• Natural Absorbable Suture (FDA Code: GAL / 878.4830) An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation. |
• Non-absorbable Suture Anchors |
• Non-Absorbable Sutures (FDA Code: GAO / 878.4495) |
• Ophthalmic Absorbable Suture (FDA Code: HMO) |
• Ophthalmic Non-Absorbable Suture (FDA Code: HMN) |
• Ophthalmology, Surgical Instrument Trays |
• Piston Syringe (FDA Code: FMF / 880.5860) A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. |
• Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR / 878.5020) Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached. |
• Polydioxanone (PDO) Monofilament Synthetic Absorbable Suture |
• Polyester Synthetic Non-Absorbable Suture (FDA Code: GAS / 878.5000) Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached. |
• Polyethylene Synthetic Non-Absorbable Suture (FDA Code: GAT / 878.5000) |
• Polyglycolic Acid Synthetic Absorbable Suture (FDA Code: GAM / 878.4493) An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percentl-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures;" it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached. |
• Polymeric Surgical Mesh (FDA Code: FTL / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. |
• Polypropylene PTFE PETP Pledget and Intracardiac Patch (FDA Code: DXZ / 870.3470) An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures. |
• Polypropylene Synthetic Non-Absorbable Suture (FDA Code: GAW / 878.5010) Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached. |
• Rigid Bronchoscope Aspirating Tube (FDA Code: KTR / 874.4680) A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier. |
• Silk Non-Absorbable Suture (FDA Code: GAP / 878.5030) Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. |
• Surgical Instrument Tray (FDA Code: FSM / 878.4800) |
• Surgical Punch (FDA Code: LRY / 878.4800) |
• Surgical Retractor (FDA Code: GAD / 878.4800) |
• Surgical Retractor Systems (FDA Code: GAD / 878.4800) |
• Surgical Staplers, Circular Staplers |
• Surgical Staplers, Laparoscopic Staplers |
• Surgical Staplers, Open Clip Appliers |
• Surgical Staplers, Stainless Steel Staples |
• Surgical Staplers, Titanium Staples |
• Synthetic Absorbable Suture (FDA Code: GAN / 878.4830) |
• Temporary Pacemaker Electrode (FDA Code: LDF / 870.3680) A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator. |
• Umbilical Occlusion Device (FDA Code: FOD / 880.5950) An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant. |