BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Sharps Needle Destruction Device

    PMA: P010040 · Supplement: S001 · Decision Apr 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Sharps Needle Destruction Device
    Trade Name
    THE DISINTEGRATOR PLUS LANCE/INSULIN NEEDLE DESTRUCTON DEVICE
    PMA Number
    P010040
    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
    April 18, 2002
    Date Received
    April 16, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE DEVICE TO ADD A PORT FOR DESTRUCTION OF LANCETS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DISINTEGRATOR PLUS NEEDLE DESTRUCTION UNIT AND IS INDICATED FOR HOME USE TO DESTROY 27 TO 30 GAUGE INSULIN HYPODERMIC NEEDLES FROM 5/16 TO = INCHES IN LENGTH, ATTACHED TO INSULIN PENS AND DISPOSABLE INSULIN SYRINGES OF 1/3 CC TO 1.0 CC VOLUME IN SIZE AND LANCETS.

    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