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510(k) Data Aggregation

    K Number
    K140573
    Device Name
    WOUNDCLOT HEMOSTATIC GAUZE
    Date Cleared
    2014-11-24

    (263 days)

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

    CORE SCIENTIFIC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.
    Device Description
    Core Scientific Creations WoundClot Hemostatic Gauze device is made from regenerated cellulose, chemically treated to become water-soluble. When the regenerated cellulose contacts blood and exudates, it expands and forms into gel, adheres and creates pressure to seal wound.
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