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510(k) Data Aggregation
K Number
K133697Device Name
BREAST-MED TISSUE MARKER
Manufacturer
Date Cleared
2015-04-10
(493 days)
Product Code
Regulation Number
878.4300Why 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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