Profile: W. l. Gore & Associates, Inc. produces a wide range of products for fabric laminates, medical implants, electronic signal transmission & microfiltration. Our Gore Excluder® AAA endoprosthesis is a device designed to be a minimally invasive treatment option to patients with abdominal aortic aneurysms. Our Gore-Tex® suture is a non-absorbable ePTFE suture, which delivers the handling and performance characteristics sought by a variety of surgical specialties. GORE RESOLUT® is a regenerative membrane remains substantially intact for 16 to 24 weeks and provides remarkably soft, supple and drapeable handling. It characteristics include protective liner, a one-piece, waterproof, breathable liner that creates a barrier to protect cast padding from soiling. The waterproof surface of the liner facilitates the cleaning of urine and excrement from the skin.

FDA Registration Number: 3013164176

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• Prosthesis Alignment Device (FDA Code: IQO / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.

• Protective Padding, Cast Liners

• Retention Sutures

• Rhodamine Conjugated FAB Fragment (FDA Code: DBY / 866.5520) An immunoglobulin G (Fab fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Fab antigen-binding fragment resulting from breakdown of immunoglobulin G antibodies in urine, serum, and other body fluids. Measurement of Fab fragments of immunoglobulin G aids in the diagnosis of lymphoproliferative disorders, such as multiple myeloma (tumor of bone marrow cells), Waldenstrom's macroglobulinemia (increased immunoglobulin production by the spleen and bone marrow cells), and lymphoma (tumor of the lymphoid tissues).

• Ringed Vascular Grafts

• Silastic Dural Substitute

• Skull Sutures

• Small Diameter Vascular Graft Prosthesis (FDA Code: DYF / 870.3450) A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.

• Soft Tissue Grafts

• Soft Tissue Patch

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Superficial Femoral Artery Stent (FDA Code: NIP)

• Surgical Apparel Accessories (FDA Code: LYU / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Surgical Masks (FDA Code: FXX / 878.4040)

• Surgical Mesh (FDA Code: FTM / 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.

• Surgical Mesh, Hernia Repair Grafts

• Surgical Non Absorbable Sutures

• Surgical Patches

• Surgical Sutures

• Sutures

• Synthetic Dural Substitute

• Temporary Carotid Catheter For Embolic Capture (FDA Code: NTE / 870.1250) A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

• Temporary Intravascular Occluding Catheter (FDA Code: MJN / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

• Tissue Tunnel

• Tracheobronchial Suction Catheter (FDA Code: BSY / 868.6810) A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

• Transcatheter Septal Occluders (FDA Code: MLV)

• Tunnelers

• Ultrasonic Puls-Echo Scanner (FDA Code: IYO / 892.1560) An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Ultrasonic Pulsed Doppler Imaging System (FDA Code: IYN / 892.1550) An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Urology Surgical Drapes (FDA Code: KKX / 878.4370)

• Vascular Graft Prosthesis (FDA Code: DSY / 870.3450)

• Vascular Grafts

• Vascular Grafts Configured For Pediatric Shunts

• Vascular Surgery Adjunctive Equipment, Tunnelers

• Vessel Guard/Cover (FDA Code: MFX / 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.

• Vicryl Sutures

• Vocal Cord Medialization System (FDA Code: MIX / 874.3620) Ear, nose, and throat synthetic polymer material 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. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.

• Woven Dacron graft

• Woven Vascular Grafts

• Ylon Sutures