OPACITY + T040320Z
GUDID 03760177040113
TEKNIMED
Vertebral bone filler, non-bioabsorbable| Primary Device ID | 03760177040113 |
| NIH Device Record Key | f15c7032-1e26-4f89-95a4-b4f8dc62db85 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPACITY + |
| Version Model Number | T040320Z |
| Catalog Number | T040320Z |
| Company DUNS | 764746723 |
| Company Name | TEKNIMED |
| 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 | true |
| Manufacturing Date | true |
| 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 |
Operating and Storage Conditions
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03760177040113 [Primary] |
FDA Product Code
| NDN | Cement, Bone, Vertebroplasty |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-09-05 |
| Device Publish Date | 2015-10-16 |
Devices Manufactured by TEKNIMED
| 03760177040090 - GENTAFIX | 2025-09-10 |
| 03760177040137 - GENTAFIX | 2025-09-10 |
| 03760177043176 - GENTAFIX | 2025-09-10 |
| 03701505801020 - PureKit Syringe 1.5cc MV | 2025-04-08 |
| 03701505801037 - META+ System 1.5cc MV | 2025-04-08 |
| 03701505801075 - PUREKIT Syringes | 2025-04-08 |
| 03701505801082 - Syringes 4cc | 2025-04-08 |
| 03701505801099 - Syringes 1.5cc | 2025-04-08 |
Trademark Results [OPACITY +]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPACITY + 79041826 3583494 Live/Registered |
TEKNIMED SAS 2007-05-04 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.