| Primary Device ID | 03701089501071 |
| NIH Device Record Key | ba15d511-145c-4522-99a9-fff4a73f6462 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VENTO Fixation Screw |
| Version Model Number | 1-01-12-9145 |
| Company DUNS | 634855407 |
| Company Name | AMPLITUDE SAS |
| 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 | 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 |
| Phone | +0033475418741 |
| regulatoryaffairs@amplitude-ortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701089501071 [Primary] |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-02-19 |
| Device Publish Date | 2017-12-22 |
| 03701089514408 | 1-01-12-9170 |
| 03701089514392 | 1-01-12-9165 |
| 03701089514385 | 1-01-12-9160 |
| 03701089514378 | 1-01-12-9155 |
| 03701089514361 | 1-01-12-9150 |
| 03701089514354 | 1-01-12-9140 |
| 03701089514347 | 1-01-12-9135 |
| 03701089514330 | 1-01-12-9130 |
| 03701089514323 | 1-01-12-9125 |
| 03701089514316 | 1-01-12-9120 |
| 03701089514309 | 1-01-12-9115 |
| 03701089501071 | 1-01-12-9145 |