OviTex®
GUDID 00810055070978
The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.
TELA BIO, INC.
Surgical implant template, reusable| Primary Device ID | 00810055070978 |
| NIH Device Record Key | efdf3bd1-bc0f-458f-b01f-bf188ffa7f4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OviTex® |
| Version Model Number | F10375-1712T |
| Company DUNS | 078721472 |
| Company Name | TELA BIO, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com |
Device Dimensions
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
| Length | 17 Centimeter |
| Width | 12 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810055070978 [Primary] |
FDA Product Code
| FZX | Guide, Surgical, Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
[00810055070978]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-27 |
| Device Publish Date | 2024-08-19 |
On-Brand Devices [OviTex® ]
| 00856072005272 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005548 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005531 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005555 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005579 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005562 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005586 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005623 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005616 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00810055070923 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00810055070916 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005630 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005654 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00856072005647 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00810055070961 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00810055070978 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00810055071081 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00810055071159 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
| 00810055071166 | The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cuttin |
Trademark Results [OviTex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OVITEX 86761323 5065654 Live/Registered |
TELA Bio, Inc. 2015-09-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.