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510(k) Data Aggregation

    K Number
    K012746
    Device Name
    ICE BATON
    Manufacturer
    BEHIVE LTD
    Date Cleared
    2001-11-14

    (90 days)

    Product Code
    LKX
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEHIVE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ice Baton is intended to provide relief from pain and discomfort due to hemorrhoids
    Device Description
    The Ice Baton is a suppository-shaped medical device designed to provide relief from the pain and discomfort due to hemorrhoids. The Ice Baton consists of an applicator cover and applicator. During use, the cover is removed and the Ice Baton applicator is filled with bottled or drinking water. The applicator cover is placed back on the Ice Baton and excess water is removed. The Ice Baton is placed in the user's freezer until frozen. After the Ice Baton is removed from the freezer, the applicator cover is removed and the Ice Baton is applied to the target hemorrhoid area. It is maintained on that area until the ice has melted or relief is felt. The Ice Baton is a disposable device.
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