OviTex® PRS
GUDID 00856072005029
OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
TELA BIO, INC.
Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite| Primary Device ID | 00856072005029 |
| NIH Device Record Key | f471820c-56a0-493f-a07d-fcdf0d4ac5fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OviTex® PRS |
| Version Model Number | R20252-0815G |
| 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
Device Dimensions
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
| Length | 8 Centimeter |
| Width | 15 Centimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856072005029 [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 | 2020-05-25 |
| Device Publish Date | 2020-05-15 |
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 |
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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