Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K201577
    Device Name
    MatriDerm
    Date Cleared
    2021-01-07

    (210 days)

    Product Code
    Regulation Number
    N/A
    Why 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.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1