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510(k) Data Aggregation

    K Number
    K161067
    Device Name
    Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
    Manufacturer
    ENGINEERED TISSUE SOLUTIONS, LLC
    Date Cleared
    2016-09-15

    (153 days)

    Product Code
    QSZ, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENGINEERED TISSUE SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first and second degree burns, skin tears) and draining wounds.
    Device Description
    The Mirragen™ Advanced Wound Matrix is composed solely of biocompatible and resorbable borate glass fibers and particulate. The borate glass constituent is medical-grade. The device is a resorbable fiber dressing that covers the wound. It may be used for a period of 3 to 7 days. The porosity of the device allows for absorption of fluid.
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