Identity
- Trade Name
- BIO-FEATHER FDA UDI
- Generic Name
- End-cut biopsy gun handpiece/needle FDA UDI
- Device Name
- Semi-automatic disposable biopsy system with adjustable penetration depth 12G X 100 MM FDA UDI
- Model / Reference
- BF12100-C2 FDA UDI
- Description
- Semi-automatic disposable biopsy system with adjustable penetration depth 12G X 100 MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053839013798 FDA UDI
- 510(k) Number
- K142125 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
- 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
Category: End-cut biopsy gun handpiece/needle
Bio-Feather by Medax Unipersonale Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as End-cut biopsy gun handpiece/needle.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Themy — M.D.L. S.R.L. · Class II
- Tru-Core™ II Biopsy Instrument — Argon Medical Devices, Inc. · Class II
- SemiCut — M.D.L. S.R.L. · Class II
- SuperCore™ Biopsy Instrument — Argon Medical Devices, Inc. · Class II
- Tru-Core™ II Biopsy Instrument — Argon Medical Devices, Inc. · Class II
- SemiCut Coax. — M.D.L. S.R.L. · Class II
- SuperCore Advantage™ — Argon Medical Devices, Inc. · Class II
Cleared under the same submission
K142125 also covers:
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
- BIO-FEATHER — Medax Unipersonale Srl
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medax Unipersonale Srl
Sources (1)
- FDA UDI 2187b6a9-18f5-4201-84f7-4ff9931f0a71 34 fields · synced May 30, 2026