TELAMax F10068-0408
GUDID 10856072005132
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.
TELA BIO, INC.
Multi-purpose surgical mesh, biologic-polymer composite| Primary Device ID | 10856072005132 |
| NIH Device Record Key | 9658502b-bfda-4b2e-b955-1a62a856bf4b |
| Commercial Distribution Discontinuation | 2016-05-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TELAMax |
| Version Model Number | F10068-0408 |
| Catalog Number | F10068-0408 |
| Company DUNS | 078721472 |
| Company Name | TELA BIO, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com | |
| Phone | (844) 835-2246 |
| customerservice@telabio.com |
Device Dimensions
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
| Length | 8 Centimeter |
| Width | 4 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10856072005132 [Primary] |
FDA Product Code
| FTM | Mesh, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-06 |
| Device Publish Date | 2015-09-17 |
On-Brand Devices [TELAMax]
| 10856072005132 | TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) an |
| 10856072005026 | TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) an |
Trademark Results [TELAMax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TELAMAX 86011025 not registered Dead/Abandoned |
TELA BIO, Inc. 2013-07-16 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.