| Primary Device ID | 08053175003439 |
| NIH Device Record Key | c0f3ca57-2e39-4373-b0ba-dfa08df82d12 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vertebroplasty Injector Kit |
| Version Model Number | 49000001 |
| Company DUNS | 437941789 |
| Company Name | ADRIA SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08053175003439 [Primary] |
| OAR | Injector, Vertebroplasty (Does Not Contain Cement) |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[08053175003439]
Ethylene Oxide
[08053175003439]
Ethylene Oxide
[08053175003439]
Ethylene Oxide
[08053175003439]
Ethylene Oxide
[08053175003439]
Ethylene Oxide
[08053175003439]
Ethylene Oxide
[08053175003439]
Ethylene Oxide
[08053175003439]
Ethylene Oxide
[08053175003439]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-15 |
| Device Publish Date | 2025-04-07 |
| 08033737113790 - HERNIATOME | 2025-04-15 Percutaneous Discectomy Device |
| 08033737119983 - HERNIATOME | 2025-04-15 Percutaneous Discectomy Device |
| 08053175003439 - Vertebroplasty Injector Kit | 2025-04-15 Vertebroplasty Set |
| 08053175003439 - Vertebroplasty Injector Kit | 2025-04-15 Vertebroplasty Set |
| 08053175004238 - Hollow Drill | 2025-04-15 DRILL |
| 08053175004382 - Cement Injection Cannula | 2025-04-15 Cement injection cannula |
| 08053175016125 - Vertebroplasty Needle | 2025-04-15 |
| 08033737117538 - Trocar | 2024-08-21 |
| 08033737117545 - Trocar | 2024-08-21 |