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510(k) Data Aggregation
K Number
K140820Device Name
XENOMEM WOUND MATRIX
Manufacturer
Date Cleared
2015-06-26
(451 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
VISCUS BIOLOGICS LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
XenoMem™ Wound Matrix is indicated for the management of wounds including:
- · Partial and full-thickness wounds;
- · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers;
- · Tunnelled/undermined wounds
- · Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound deliscence),
- · Trauma wounds (abrasions, lacerations, second-degree burns, skin tears);
- Draining wounds.
Device Description
XenoMem™ Wound Matrix is an acellular, porcine peritoneal matrix, supplied sterile to maintain and support an environment for wound management. It consists of an extracellular tissue matrix, derived from porcine peritoneum. XenoMem™ Wound Matrix porcine peritoneal membrane provides a robust biological matrix that allows for easier handling during preparation and application of the wound dressing. The membrane has undergone a decellularisation, viral inactivation and a freeze-drying process in order to remove donor genetic material, in a non-destructive manner, so as to maintain the structure and function of the tissue. XenoMem is sterilized via gamma irradiation and sold for prescription only.
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