Primary Device ID | 10856072005088 |
NIH Device Record Key | 66a7082e-7d49-47af-b7aa-bb69fa8584c3 |
Commercial Distribution Discontinuation | 2016-05-10 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | TELAMax 1S |
Version Model Number | F10069-1822 |
Catalog Number | F10069-1822 |
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 |
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 |
00810055071081 - OviTex® | 2024-10-23 The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow |
00810055070978 - OviTex® | 2024-08-27 The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow |
00810055070961 - OviTex® | 2024-06-17 The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow |
00810055070183 - OviTex® PRS | 2023-07-20 OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring sof |
00810055070275 - OviTex® PRS | 2023-07-20 OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring sof |
00810055070442 - OviTex® PRS | 2023-07-20 OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring sof |
00810055070619 - OviTex® PRS | 2023-07-20 OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring sof |
00810055070770 - OviTex® PRS | 2023-07-20 OviTex® PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring sof |