Identity
- Trade Name
- TELAMax FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
- Device Name
- TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements. FDA UDI
- Model / Reference
- F10068-0408 FDA UDI
- Description
- TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements. FDA UDI
Identifiers
- Catalog Number
- F10068-0408 FDA UDI
- Primary DI / UDI-DI
- 10856072005132 FDA UDI
- FDA Product Code
- FTM FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, biologic-polymer composite FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Length — 8 Centimeter FDA UDIWidth — 4 Centimeter FDA UDI
TELAMax by TELA Bio, Inc. — 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
- TELA Bio, Inc.
Sources (1)
- FDA UDI 9658502b-bfda-4b2e-b955-1a62a856bf4b 38 fields · synced May 30, 2026