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510(k) Data Aggregation
K Number
K963228Device Name
REPLIDERM WOUND DRESSING
Manufacturer
Date Cleared
1996-12-18
(121 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ORPHAN MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Repliderm™ Wound Dressing cartilage powder is a collagen based powder intended for use in the management of pressure ulcers (stages I - IV), stasis ulcers, 1st and 2nd degree burns, diabetic ulcers, foot ulcers, post surgical incisions, radiation dermatitis, cuts, abrasions, irritations of the skin, partial thickness wounds and skin conditions associated with peristomal care.
Repliderm™ Wound Dressing has also been shown to be useful for wound exudate absorption.
Device Description
Repliderm™ Wound Dressing is a collagen based product containing approximately 73% protein, 18% carbohydrates, and 5% other cartilage components. The particles, average particle size of approximately 35 microns, are composed of the natural three-dimensional network of macromolecular chains of cross-linked collagen, which is large enough to allow substances with a molecular weight of less than 1,000 to freely enter. Substances with a molecular weight of 1,000 to 5,000 enter the particles less freely, while those substances with larger molecular weights remain in the interspaces between the particles.
Each gram of wound dressing powder can absorb approximately 3-4 ml of fluid. Its other wound healing properties derive from an average 35 micron particle size, combined with the materials biocompatibility and biodegradation characteristics.
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