Identity
- Trade Name
- TiO2Mesh FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
- Device Name
- TiO2Mesh surgical mesh implant for hernia repair made of 100% Polypropylene with titanium oxide surface coating. Size 25cm x 20cm / 10" x 8" oval FDA UDI
- Model / Reference
- MFP133 FDA UDI
- Description
- TiO2Mesh surgical mesh implant for hernia repair made of 100% Polypropylene with titanium oxide surface coating. Size 25cm x 20cm / 10" x 8" oval FDA UDI
Identifiers
- Catalog Number
- MFP133 FDA UDI
- Primary DI / UDI-DI
- EBCBMFP1330 FDA UDI
- 510(k) Number
- K113311 FDA UDI
- FDA Product Code
- OXJ FDA UDIFTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable 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, synthetic polymer, non-bioabsorbable
TiO2Mesh by Biocer Entwicklungs GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable.
- COMPOSIX — Davol Inc. · Class II
- SurgiMesh — BG MEDICAL, LLC · Class II
- HERMESH — Herniamesh · Class II
- Hermesh — Herniamesh · Class II
- HERMESH — Herniamesh · Class II
- BARD — Davol Inc. · Class II
- Bard — Davol Inc. · Class II
- 3DMAX — Davol Inc. · Class II
Cleared under the same submission
K113311 also covers:
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
- TiO2Mesh — Biocer Entwicklungs GmbH
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
- Biocer Entwicklungs GmbH
Sources (1)
- FDA UDI d15fdd21-ffd9-49ad-92c8-5074c2d5af2e 35 fields · synced May 30, 2026