Primary Device ID | 09421905067768 |
NIH Device Record Key | 2fc0cb13-71c3-4bbb-a36c-ce31c3da6a23 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ovitex® PRS |
Version Model Number | R20253-0717G |
Company DUNS | 594540572 |
Company Name | AROA BIOSURGERY LIMITED |
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 |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 25 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09421905067768 [Primary] |
FTM | Mesh, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-11-11 |
Device Publish Date | 2019-11-01 |
09421905067904 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067898 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067881 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067874 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067867 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067850 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067843 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067836 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067829 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067812 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067805 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067799 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067782 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067775 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067768 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067751 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067744 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067737 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067720 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067713 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067706 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067690 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067683 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067676 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067669 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067652 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067645 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067638 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067157 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421905067140 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421906017052 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
09421906017045 | Ovitex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requ |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OVITEX 86761323 5065654 Live/Registered |
TELA Bio, Inc. 2015-09-18 |