BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Sharps Needle Destruction Device

    PMA: P960044 · Supplement: S001 · Decision Feb 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    NEEDLE-EASE MODEL 3500
    PMA Number
    P960044
    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 11, 1998
    Date Received
    October 3, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a modified needle destruction device. The device, as modified, will be marketed under the trade name Needle-Ease(R) 3500 and is indicated for the disposal of standard plstic syringe-mounted hypodermic needles and aluminum hubbed dental needles in doctor's and dentist's offices.

    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