Identity
- Trade Name
- Xpress BCD Breast Compression Device FDA UDI
- Generic Name
- Mammographic x-ray system compression paddle FDA UDI
- Device Name
- The proposed device, the XPress BCD, is used in conjunction stereotactic breast biopsy devices. The primary function of the device is to provide effective consistent mechanical breast compression following stereotactic-guided biopsy, replacing standard manual compression of post breast biopsy sites. Reliable and effective mechanical breast compression, with equivalent clinical outcomes, reduces medical staff blood exposure and allows for significant labor savings. FDA UDI
- Model / Reference
- BCD-001 FDA UDI
- Description
- The proposed device, the XPress BCD, is used in conjunction stereotactic breast biopsy devices. The primary function of the device is to provide effective consistent mechanical breast compression following stereotactic-guided biopsy, replacing standard manual compression of post breast biopsy sites. Reliable and effective mechanical breast compression, with equivalent clinical outcomes, reduces medical staff blood exposure and allows for significant labor savings. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810105030501 FDA UDI
- FDA Product Code
- POY FDA UDI
- GMDN Term
- Mammographic x-ray system compression paddle 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mammographic x-ray system compression paddle
Xpress BCD Breast Compression Device by Composite Manufacturing, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Composite Manufacturing, Inc.
Sources (1)
- FDA UDI a7c80012-b762-460a-8ef7-75ab81f23644 34 fields · synced May 30, 2026