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510(k) Data Aggregation

    K Number
    K955514
    Device Name
    SHARPS SAFE 1.5 & SHARPS SAFE 2.0
    Manufacturer
    Date Cleared
    1996-08-01

    (241 days)

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

    DURA-VAC PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sharps Safes are designed to be used by Paramedics or Home Care Providers who need a small, portable and rugged sharps container which can be used in remote locations to dispose of contaminated needles.
    Device Description
    The device is comprised of a 1.5 inch diameter plastic tube (model 1.5), or a 2.0 diameter plastic tube (model 2.0). Securely attached to each end is a plastic cap. Secured inside the cap attached to the bottom end is a hard plastic disc designed to prevent needle penetration. The cap on the top end has a ¼ inch hole in the center. Radiating from the hole are slits cut in the plastic which form flaps through which a sharps can be inserted. A vinyl cover is provided for the top to provide a moisture tight seal.
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