OviTex® PRS R20143-0820P
GUDID 00856072005050
The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
TELA BIO, INC.
Extra-gynaecological surgical mesh, biologic-polymer composite| Primary Device ID | 00856072005050 |
| NIH Device Record Key | 9fcef6f3-5afb-43e7-a190-a8e95fc685a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OviTex® PRS |
| Version Model Number | R20143-0820P |
| Catalog Number | R20143-0820P |
| Company DUNS | 078721472 |
| Company Name | TELA BIO, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | 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 | |
| Phone | 1-844-835-2246 |
| customerservice@telabio.com |
Device Dimensions
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
| Length | 8.5 Centimeter |
| Width | 20 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856072005050 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K183398
FDA Product Code
| FTM | Mesh, Surgical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-03 |
| Device Publish Date | 2025-02-21 |
On-Brand Devices [OviTex® PRS]
| 00856072005289 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005036 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005029 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005012 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005005 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005197 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005135 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005111 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005104 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005074 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005043 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00856072005142 | OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
| 00810055070855 | OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness |
| 00810055070770 | OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness |
| 00810055070619 | OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness |
| 00810055070442 | OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness |
| 00810055070275 | OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness |
| 00810055070183 | OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness |
| 00856072005050 | The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised |
| 00810055071074 | The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised |
| 00810055071067 | The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised |
Trademark Results [OviTex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OVITEX 86761323 5065654 Live/Registered |
TELA Bio, Inc. 2015-09-18 |
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