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510(k) Data Aggregation

    K Number
    K133697
    Device Name
    BREAST-MED TISSUE MARKER
    Manufacturer
    Date Cleared
    2015-04-10

    (493 days)

    Product Code
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    BREAST-MED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Breast-Med Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
    Device Description
    The Breast-Med Tissue Marker is a sterile, nonpyrogenic, single use tissue marker consisting of a polymeric tube filled with a dessicated solution of sodium chloride with trace amounts of gadolinium chelate that is visible on standard radiographs (x-ray, mammography) as well as ultrasound and Magnetic Resonance Imaging (MRI). The tissue marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
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