Identity
- Trade Name
- AFFIRM™ CONTRAST BIOPSY FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices. FDA UDI
- Model / Reference
- AFFIRM™ CONTRAST BIOPSY SOFTWARE FDA UDI
- Description
- Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices. FDA UDI
Identifiers
- Catalog Number
- CMP-01771 FDA UDI
- Primary DI / UDI-DI
- 15420045512948 FDA UDI
- 510(k) Number
- K103512 FDA UDI
- FDA Product Code
- IZH FDA UDI
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mammographic stereotactic biopsy system
Affirm™ Contrast Biopsy by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (1)
- FDA UDI cdff0717-26ac-4df0-bb3b-44dc674a0761 36 fields · synced May 30, 2026