Identity
- Trade Name
- BioBrace 5mm FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Model / Reference
- BB5X250 FDA UDI
Identifiers
- Catalog Number
- BB5X250 FDA UDI
- Primary DI / UDI-DI
- 00860006566708 FDA UDI
- 510(k) Number
- K203267 FDA UDI
- FDA Product Code
- OWW FDA UDIOWY FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
MR Safe FDA UDI
Category: Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
BioBrace 5mm by Biorez, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.
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- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium — Smith & Nephew, Inc. · Class II
- Permacol — SOFRADIM PRODUCTION · Class II
- XENMATRIX — Davol Inc. · Class II
Cleared under the same submission
K203267 also covers:
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
- Biorez, Inc.
Sources (1)
- FDA UDI f2d659ba-db4f-4511-ae82-52702a77ff33 36 fields · synced Jun 8, 2026