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510(k) Data Aggregation

    K Number
    K110318
    Device Name
    EXCELLAGEN
    Manufacturer
    TISSUE REPAIR COMPANY
    Date Cleared
    2011-10-03

    (243 days)

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

    TISSUE REPAIR COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Excellagen is indicated for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. This device is packaged for one-time use.
    Device Description
    Excellagen is a wound care device composed of formulated, 2.6% (26 mg/mL) fibrillar bovine dermal collagen (Type I) that is topically applied directly to the wound surface. Excellagen is packaged as single-use units to ensure safety and provide for easy topical application. The device is tested for sterility in accordance with USP<71>. Excellagen is supplied in one of two kit configurations. One kit configuration consists of four single-use 1.0 cc syringes, each containing 0.5 cc of 2.6% (26 mg/mL) formulated collagen, and four singleuse sterile flexible applicators. This kit can be used for smaller wounds. The second kit configuration consists of one single-use 10.0 cc syringe containing 4.0 cc of 2.6% (26 mg/mL) formulated collagen, and one single-use sterile flexible applicator. This kit can be used for larger or tunneling/undermined wounds. Excellagen is stored at standard refrigeration temperature (2-8°C). During manufacture, the collagen component of Excellagen is purified using a specialized process that eliminates impurities (including endotoxins), and removes denatured molecules and collagen fragments. Excellagen consists almost exclusively of high molecular weight, intact, fibrillar collagen and is formulated at a concentration of 2.6% (26 mg/mL) in an isotonic buffer with protein stabilizing agents.
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