BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Sharps Needle Destruction Device

    PMA: P010040 · Supplement: S002 · Decision Apr 4, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    DISINTEGRATOR PRO NEEDLE DESTRUCTION DEVICE
    PMA Number
    P010040
    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
    April 4, 2003
    Date Received
    February 24, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CLINICAL USE OF THE DEVICE, THE COMPONENTS AND SHIELDING TO MINIMIZE EMI LEVELS, A HIGHER CURRENT CAPACITY FOR AC OPERATION AND TWO ADAPTERS TO ACCOMMODATE DESTRUCTION OF CONVENTIONAL NEEDLES RANGING IN SIZE FROM 5/16 TO 1 INCH IN LENGTH AND 20-30 GAUGE THAT ARE ATTACHED TO 1 TO 3 CC SYRINGES. THE DEVICE, AS MODIFIED, WHICH WILL BE MARKETED UNDER THE TRADE NAME DISINTEGRATOR PRO, IS A SHARPS NEEDLE DESTRUCTION DEVICE FOR CLINICAL USE THAT IS INDICATED FOR THE DESTRUCTION OF LANCETS AND 20 TO 30 GAUGE NEEDLES FORM 5/16 TO 1 INCH IN LENGTH.

    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