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510(k) Data Aggregation

    K Number
    K052725
    Device Name
    PROTECTOR NEEDLE SHEATH PROP
    Manufacturer
    CERTOL INTERNATIONAL, LLC
    Date Cleared
    2005-12-28

    (90 days)

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

    CERTOL INTERNATIONAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ProTector™ Needle Sheath Prop is a disposable, non-sterile device that can be used to safely uncap and recap needles using a one-handed technique. ProTector™ Needle Sheath Prop facilitates OSHA requirements by reducing the possibility of accidental needle sticks and discourages leaving the needle unsheathed on the tray. The Prop is autoclavable for one-time sterile tray set-up. It holds the cap securely in the ready position.
    Device Description
    The ProTector™ Needle Sheath Prop is a disposable, non-sterile, one-time use device that can be used to safely uncap and recap needles using a one-handed technique. The ProTector™ facilitates and meets OSHA's Bloodborne Pathogens requirement to promote reduction in accidental needle sticks. Use of the ProTector™ discourages leaving the needle unsheathed on an instrument trav. The device is specifically designed to capture the needle cover/cap and hold it in the ready position. The ProTector™ is manufactured using a premium grade rectangular paper board card. The sheathed needle cap is inserted into the targeted hole up to the cover hub, securing the needle cover firmly in the ProTector™. The targeted hole is designed as a flexible press-fit to accommodate all sizes of needle protector cover up to 3/8" OD which accommodates most needle covers on the market. After the needle and cover is inserted into the ProTector™, it is now in the ready position to be able to safely withdraw the needle. The rectangular shape of the ProTector™ allows the loaded needle cover to be propped on the dental or medical tray.
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