BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Sharps Needle Destruction Device

    PMA: P120018 · Supplement: S001 · Decision Feb 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    Sharps Terminator
    PMA Number
    P120018
    Supplement Number
    S001
    Device Class
    FDA Class 2
    Product Code
    MTV
    Generic Name
    Sharps needle destruction device
    Regulation Number
    880.6210
    Medical Specialty
    General Hospital
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 16, 2018
    Date Received
    May 25, 2017
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Global Machining Industries, 28 Xinchang Road, 2nd Floor, Suzhou Industrial Park, Suzhou 21500, China, Manufacturing.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MTV Sharps Needle Destruction Device