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510(k) Data Aggregation
K Number
K201577Device Name
MatriDerm
Manufacturer
Date Cleared
2021-01-07
(210 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MedSkin Solutions Dr. Suwelack AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MatriDerm is indicated for the management of wounds including:
- Full thickness and partial thickness wounds
- Chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers)
- Surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
- Partial thickness burns
- Trauma wounds (abrasions, lacerations and skin tears)
- Draining wounds
Device Description
MatriDerm is a single-use three-dimensional acellular dermal matrix composed of bovine collagen fibers and bovine elastin. The device is supplied sterile and is available in different sizes providing flexibility of choice based on the treatment protocol, wound location, size and depth. The device can be cut to fit the wound.
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