BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Sharps Needle Destruction Device

    PMA: P010065 · Supplement: S002 · Decision Feb 5, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    NEEDLE ZAP
    PMA Number
    P010065
    Supplement Number
    S002
    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 5, 2004
    Date Received
    November 12, 2003
    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 FRANTZ MEDICAL DEVELOPMENT, LTD., MENTOR, OHIO.

    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