Identity
- Trade Name
- Biopsy Handy FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Model / Reference
- 900128 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250195601889 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- End-cut biopsy gun handpiece/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Biopsy Handy by SOMATEX Medical Technologies GmbH — 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
- SOMATEX Medical Technologies GmbH
Sources (1)
- FDA UDI 5114654d-84a3-46ab-8e97-dbdb9c192ddb 33 fields · synced Jun 6, 2026