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510(k) Data Aggregation

    K Number
    K170513
    Device Name
    MAUSER PG II Sharps Container
    Manufacturer
    Mauzer USA LLC
    Date Cleared
    2017-11-01

    (253 days)

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

    Mauzer USA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAUSER PG II Sharps Container is intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, veterinarian offices and other waste generators for the safe collection and disposal of hazardous sharps. MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access.
    Device Description
    MAUSER PG II Sharps Container is a single-use device, which consist of rectangular body and available in three sizes 30 liter, 50 liter and 60 liter. Each container has two parts, the body and the lid, which assemble together to form a unit. Two lid styles are available: grip, and click with port hole. MAUSER PG II Sharps Container is designed for use on sites with no unsupervised patient access. Manufacturer offers a stainless steel pedal frame cart that offers a hands free collection process and integrates with all sizes of container and lid type. The container is designed for safe collection and disposal of sharps, i.e. items that can cause puncture wounds, cuts or tears in skin or mucous membranes, including, but not limited to hypodermic, surgical, suture, and IV needles; Pasteur pipets, lancets, razors, scalpels, and other blades.
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