Profile: Prime Medical, Inc. manufactures products for orthopedic immobilization. Our products include Primecast™, Splint™, Pop Splint™, Pad™, Net™, Cutter™, Crepe™, Cop™, Cob™, Por™, Trans™ and Dermaguard™. Primecast™ is a synthetic casting tape impregnated with polyurethane resin, which is activated by water before use. Primesplint™ is composed of eight layers of polyester casting strips impregnated with polyurethane resin. This strip is encased in a non-woven protective barrier on both sides to provide cushioning for patient comfort. Its extreme strength and convenience of application is suitable for temporary immobilization of fractures, sprains and strains. Primecutter™ has a high precision, low-noise, high speed cast cutter. Trans™, is a transparent microperforated hypoallergenic tape made of perforated polyethylene tape. It has an acrylate adhesive that does not harm patients who have sensitive skin. It has high permeability to both air and water vapor. Primecob™ is an elastic non-woven bandage with latex coating, cohesive on both sides, permeable to air and water vapor. It is a non-slip dressing for pre- and post-operative thromboprophylaxis. Pad™ is a hypo-allergenic surgical tape made of non-woven backing material.
FDA Registration Number: 3010000970
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• Adhesive Bandages (FDA Code: KGX / 880.5240) A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. |
• Adhesive Tape |
• Bandages |
• Cast Bandage (FDA Code: ITG / 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. |
• Casting Tapes |
• Cohesive Bandages |
• Cotton Tape |
• Fabric Bandages |
• First Aid Bandage |
• Hydrophilic Wound Dressings (FDA Code: NAC / 878.4018) A hydrophilic wound dressing is a sterile or non-sterile device intended to cover a wound and to absorb exudate. It consists of nonresorbable materials with hydrophilic properties that are capable of absorbing exudate (e.g., cotton, cotton derivatives, alginates, dextran, and rayon). This classification does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. |
• Orthopedic Tape (FDA Code: HXT / 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. |
• Self-Adhesive Wound Dressing |
• Wound Care Dressings |
• Wound Dressings |