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510(k) Data Aggregation

    K Number
    K101567
    Device Name
    SHARPS CONTAINER
    Date Cleared
    2010-09-02

    (90 days)

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

    CIXI LEINUO PLASTIC CO. LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The sharps container are intended to be used in healthcare facilities, including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian office and other small quantity waste generators for the safe disposal of hazardous sharps.
    Device Description
    The Sharps Container is a piece of equipment used in hospitals, physicians' offices, dental offices, laboratories, home health areas, patient rooms and other locations of medical waste. The sharps container is designed to safely contain used needles or syringes and prevent accidental needle sticks from used syringes or needles. The device is made of injected molded polypropylene material. The material . is made of molded plastic into a specific shape. The actual shape is designed to sit on the floor or a desk. On the outer casing of all the sharps containers is the Biohazard Warning label in Orange, noticeably displayed. The molded plastic container is designed and manufactured such that there . will be no leakage during storage, handling or transport.
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