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510(k) Data Aggregation

    K Number
    K160130
    Device Name
    BloodSTOP iX Battle Matrix
    Date Cleared
    2016-06-29

    (161 days)

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

    LifeSciencePLUS Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BloodSTOP iX Battle Matrix is indicated for external temporary control of minor to moderate bleeding of traumatic wounds.
    Device Description
    BloodSTOP iX Battle Matrix is a biocompatible, non-irritating, woven matrix of fibers made from cellulose. Using a proprietary process, regenerated cellulose is etherified and oxidized to make a watersoluble, hemostatic matrix. When applied to a wound, BloodSTOP® iX Battle Matrix absorbs blood and other body fluids, transforms into a gel, actively aids in blood coagulation, and adheres to the wound with a protective translucent layer. BloodSTOP iX exerts its pro-coagulant activity by activating the intrinsic coagulation pathway, accelerating clot formation. Its water solubility allows for easy removal through rinsing without disruption of the clotted wound surface. BloodSTOP iX Battle Matrix is provided sterile in a simple to use format that readily conforms to a wound: 3"x24" strip, z-folded to an 8-layer 3"x3" pad.
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