Breast Biopsy Probe
- UID
- IMP/MD/2022/000759_808cac49a1507ae5ebb18fc8f803e969_3721922e32c1eab45b25e907e637177e
- Device class
- Class B
- Brand name
- EnCor® Breast Biopsy Probe
- License holder
- M/s Bard India Healthcare Private Limited
- Approving authority
- CDSCO
- Product information
- The EnCor® Breast Biopsy Probe and MRI breast probes are indicated to acquire tissue for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic or imaged appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Breast Biopsy Probe is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000759_808cac49a1507ae5ebb18fc8f803e969_3721922e32c1eab45b25e907e637177e. This device is marketed under the brand name EnCor® Breast Biopsy Probe. The license holder is M/s Bard India Healthcare Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.
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