Profile: Systagenix Wound Management Manufacturing Limited is engaged in the production of wound care products. Our product line comprises of Actisorb™ silver 220, Bioclusive™ transparent film, Dyna-Flex™ multilayer compression system, fibracol™ plus, promogran™ matrix, Promogran Prisma™ matrix, Regranex™ gel, Silvercel™, Tielle™ and Tielle™ plus hydropolymer dressing products. Our Actisorb™ silver 220 reduces infection in partial and full-thickness wounds. Its embedded silver particles kill bacteria and fungi, while a highly porous activated charcoal layer binds toxins and odour-causing molecules. Our Bioclusive™ transparent film dressing provides a bacterial/viral barrier, allow oxygen vapor transfer, permit continuous observation, and feature easy stretch removal which helps to reduce skin irritation. We supply Dyna-Flex™ multilayer compression system that provides sustained compression for up to seven days at both the ankle and below the knee. Our fibracol™ plus maintains a moist wound environment which is conducive to granulation tissue formation and epithelialization that enables healing to proceed optimally. Our Silvercel™ antimicrobial alginate dressing kills a broad spectrum of microorganisms associated with the bacterial colonization and infection of wounds. We also offer Tielle™ and Tielle™ plus hydropolymer dressings that are used to cover all wound types and in combination with other wound care products.
FDA Registration Number: 3007663067
US Agent: Steven Jackson / Kci Usa Inc
Phone: +1-(210)-255-6438 Fax: +1-(210)-255-6727 E-Mail:
12 Products/Services (Click for related suppliers)
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• Collagen Wound Dressing (FDA Code: KGN) |
• Drug Wound Dressing (FDA Code: FRO) |
• Hydrogel Wound and Burn Dressing (FDA Code: MGQ) |
• Hydrogel Wound Dressing (W/Out Drug And/Or Biologic) (FDA Code: NAE / 878.4022) A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel 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. |
• 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. |
• Liquid Bandage (FDA Code: KMF / 880.5090) A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. |
• Medical Device, Sterilant (FDA Code: MED / 880.6885) A 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. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin. |
• Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014) A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. |
• Occlusive Wound and Burn Dressing (FDA Code: MGP) |
• Occlusive Wound Dressing (FDA Code: NAD / 878.4020) An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive 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. |
• Wound Dressing Kit (FDA Code: MCY / 880.5075) |
• Wound Exudate Absorption Hydrophilic Beads (FDA Code: KOZ / 878.4018) |