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    K Number
    K122704
    Device Name
    BEST LOCALIZATION NEEDLE WITH I-125 SEED
    Manufacturer
    BEST MEDICAL INTL.
    Date Cleared
    2013-01-09

    (127 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEST MEDICAL INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated as "single-use sterile device". Best Localization Needle with I-125 Seed is indicated in the use for Breast Localization purpose under the direct supervision of a qualified physician.
    Device Description
    "Best" Localization Needle with I-125 Seed" contains low activity Iodine seed (Best I-125- K912170). The lodine-125 seed is loaded as loose or as stranded inside the needle. Most commonly, 18 giuge 5cm to 20 cm needles are used as a breast localization needle to facilitate the introduction of radionuclide seed into the breast cancer area. The devices are packaged in a pouch with label and provided sterile.
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