| Primary Device ID | 03663136033358 |
| NIH Device Record Key | fde93a7b-d3e7-449c-87c8-0fd0a24c7d17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U.L.I.S™ |
| Version Model Number | IS1-A317 |
| Company DUNS | 390377518 |
| Company Name | SPINEVISION |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com | |
| Phone | +33153332525 |
| corp.quality@spinevision.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03663136033358 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03663136033358]
Moist Heat or Steam Sterilization
[03663136033358]
Moist Heat or Steam Sterilization
[03663136033358]
Moist Heat or Steam Sterilization
[03663136033358]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-12-19 |
| Device Publish Date | 2018-09-04 |
| 03663136033556 | ULIS Identification Plate |
| 03663136033433 | Screws Rack |
| 03663136033426 | Tray 5 ULIS |
| 03663136033419 | Tray 4 ULIS |
| 03663136033396 | Tray 2 ULIS |
| 03663136033389 | Tray 1 ULIS |
| 03663136033365 | Reduction screwdriver |
| 03663136033358 | Persuader |
| 03663136033341 | Inner Tube for Persuader |