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    K Number
    K960933
    Device Name
    BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
    Manufacturer
    BIO-PLEXUS, INC.
    Date Cleared
    1996-08-28

    (174 days)

    Product Code
    FMI,REA
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIO-PLEXUS NEEDLE DISPOSAL CONTAINER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BIO-PLEXUS™ Needle Disposal Container is to be used by healthcare workers in healthcare facilities and in the home healthcare setting for the disposal of contaminated PUNCTUR-GUARD® needles and accessories.

    Device Description

    The BIO-PLEXUS™ Needle Disposal Container is a single use, one quart, puncture resistant container comprised of a bucket like base and an affixed cover. The bucket and the cover are plastic injection molded from polypropelene. The cover has three openings and two hinged lids.

    AI/ML Overview

    I am sorry, but the provided text describes a medical device, specifically a "Needle Disposal Container," and its intended use. It does not contain any information about clinical studies, performance metrics, acceptance criteria, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as none of that information is present in the input text.

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