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510(k) Data Aggregation

    K Number
    K042907
    Device Name
    NEEDLE INCAPACITATOR (NEEDLE GUARD)
    Manufacturer
    Date Cleared
    2004-12-22

    (62 days)

    Product Code
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    PDMP, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luce-look syringe. The Needle Guard Will accept any standard disposable syringe without a mechanical safety device and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point of promotion and syringes, into a large sharps container and/or red biohazard bag. Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard. The device is for use by health care professionals in hospitals and private practices research a laboratories, specialized medicines applications, clinics, nursing homes, home care and a laboratories, specialized medically applications, childes, thereases and exchange programs, dental offices, veterinarians, mortuaries.
    Device Description
    NEEDLE GUARD is an individual self-contained point-of-use contaminated needle and syringe sharps management system that fully encapsulates the needle of a luce-look syringe. The Needle Guard Will accept any standard disposable syringe without a mechanical safety device and one-half inches (1 ½"). It is a one-handed procedure that is used immediately after the use of the syringe at point of promotion and syringes, into a large sharps container and/or red biohazard bag. Needle Guards are prepackaged in a disposable plastic tray to be used when syringe is inserted into Needle Guard.
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