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510(k) Data Aggregation

    K Number
    K132476
    Device Name
    SHARPS CONTAINER
    Manufacturer
    Date Cleared
    2014-05-02

    (267 days)

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

    **GRP **& ASSOCIATES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.
    Device Description
    The GRP Sharps Container is a blow molded HDPE bottle with a spun-weld iris at the opening. The iris acts as an aperture, allowing a vertical sharps drop. The device has a yellow safety ring which prevents the cap from locking closed during use. The device has a white 2.5″ cap which contains a sealing gasket. Once the GRP Sharps Container is full, the safety ring is removed prior to pacing the cap on. When the safety ring has been removed, the cap locks down for a tight seal. The device is available in four sizes: 1.5 quart, 1 gallon, 2 gallon and 3 gallon. The containers are identical except for capacity.
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