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510(k) Data Aggregation

    K Number
    K090345
    Device Name
    MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL
    Date Cleared
    2010-01-07

    (331 days)

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

    CONSEAL INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MendaSil™-TWG Gel Skin and Wound Gel is indicated for use under the supervision of a healthcare professional for management of partial to full thickness wounds from mild to moderate exudate such as Stage I-IV Pressure Ulcers, Partial and Full Thickness Wounds, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Venous Stasis Ulcers and Surgical Incision Wounds. The Gel can also be used for management of minor cuts, scrapes/abrasions, and irritated skin.
    Device Description
    MendaSil™ TWG Skin and Wound Gel is an amorphous wound moisture management gel that helps maintain a moist wound environment that is conducive to healing by either absorbing the wound exudates or donating the moisture. The Gel contains a silver compound that is an effective barrier to bacterial penetration by inhibiting the growth of a broad spectrum of microorganisms which come into contact with the gel. MendaSil™-TWG Skin and Wound Gel will be supplied in conventional HDPE bottles fitted with a "flip top" dispenser closure. This bottle will be placed in a chipboard dispenser box with a package insert.
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