Identity
- Trade Name
- TiMESH FDA UDI
- Generic Name
- Pelvic organ prolapse surgical mesh, composite-polymer FDA UDI
- Device Name
- Ti-Mesh 6" X 6" Light 35g/m² FDA UDI
- Model / Reference
- 6000312 FDA UDI
- Description
- Ti-Mesh 6" X 6" Light 35g/m² FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04042301097606 FDA UDI
- 510(k) Number
- K031225 FDA UDI
- FDA Product Code
- OXJ FDA UDIFTL FDA UDI
- GMDN Term
- Pelvic organ prolapse surgical mesh, composite-polymer 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
Category: Pelvic organ prolapse surgical mesh, composite-polymer
TiMESH by pfm medical titanium gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pelvic organ prolapse surgical mesh, composite-polymer.
- Vertessa Lite Y-Mesh 26x4x3cm — CALDERA MEDICAL, INC. · Class II
- ARTISYN — Johnson & Johnson Medical, Inc. · Class II
- Vertessa Lite Y-Mesh 26x5x4cm — CALDERA MEDICAL, INC. · Class II
- Vertessa Lite Strips 4x22cm — CALDERA MEDICAL, INC. · Class II
- Vertessa Lite 10x22cm — CALDERA MEDICAL, INC. · Class II
- Vertessa Lite 10x26cm — CALDERA MEDICAL, INC. · Class II
- Vertessa Lite Y 22x5x4cm — CALDERA MEDICAL, INC. · Class II
- Vertessa Lite Y-mesh 22x4x3cm — CALDERA MEDICAL, INC. · Class II
Cleared under the same submission
K031225 also covers:
- Ti-MESH — pfm medical titanium gmbh
- Ti-MESH — pfm medical titanium gmbh
- Ti-MESH — pfm medical titanium gmbh
- Ti-MESH — pfm medical titanium gmbh
- Ti-MESH — pfm medical titanium gmbh
- Ti-MESH — pfm medical titanium gmbh
- TiMESH — pfm medical titanium gmbh
- TiMESH — pfm medical titanium gmbh
- TiMESH — pfm medical titanium gmbh
- TiMESH — pfm medical titanium 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
- pfm medical titanium gmbh
Sources (1)
- FDA UDI fa606046-b360-42ee-9dfc-9d5425b02c82 35 fields · synced Jun 8, 2026