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    K Number
    K090430
    Device Name
    BACKSTOP AND BACKSTOP INJECTOR
    Manufacturer
    PLUROMED, INC.
    Date Cleared
    2009-06-02

    (103 days)

    Product Code
    ONJ, PER
    Regulation Number
    876.4680
    Why did this record match?
    Product Code :

    ONJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BackStop is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures.
    Device Description
    BackStop™ is a self-forming polymeric plug with reverse thermosensitive properties. At room temperature it is viscous but injectable. When the temperature of the plug increases , its viscosity increases and it forms a plug that is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures. The material is water soluble and is removed by irrigating the plug with saline.
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