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510(k) Data Aggregation

    K Number
    K101257
    Device Name
    ADVANCED TRAUMA DRESSING (ATD)
    Manufacturer
    Date Cleared
    2011-12-01

    (576 days)

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

    NANOSYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prescription use: ATD is intended for temporary external use to control traumatic bleeding. Over-The-Counter-Use: ATD is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions.
    Device Description
    ATD is composed of an absorbent pad of carboxymethyl cellulose impregnated with ionic silver and then uniformly coated with silicon particles for the purpose of promoting rapid hemostasis. The hemostatic mechanism of silicon in ATD is through, contact pathway activation (intrinsic) of clot formation. The device is provided as a sterile 10 cm x 100 cm strip that is Z-folded and vacuum packed. The dressing is placed directly on the site of bleeding with applied pressure as long as necessary or until the time of definitive care.
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