| Primary Device ID | 07640332477618 |
| NIH Device Record Key | ed184488-e574-4813-8f5e-df9183bc4bc2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OPEL-L |
| Version Model Number | S1-9-00002-38 |
| Catalog Number | S1-9-00002-38 |
| Company DUNS | 483016148 |
| Company Name | SpineArt SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640332477618 [Primary] |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-28 |
| Device Publish Date | 2025-11-20 |
| 07640332477755 | OPEL-L PLATE ASSEMBLY, L38 |
| 07640332477731 | OPEL-L PLATE ASSEMBLY, L36 |
| 07640332477717 | OPEL-L PLATE ASSEMBLY, L34 |
| 07640332477694 | OPEL-L PLATE ASSEMBLY, L32 |
| 07640332477670 | OPEL-L PLATE ASSEMBLY, L30 |
| 07640332477656 | OPEL-L PLATE ASSEMBLY, L28 |
| 07640332477618 | OPEL-L IVIEW PLATE ASSEMBLY, L38 |
| 07640332477588 | OPEL-L IVIEW PLATE ASSEMBLY, L32 |
| 07640332477571 | OPEL-L IVIEW PLATE ASSEMBLY, L30 |
| 07640332477519 | OPEL-L IVIEW INLINE INSERTER |
| 07640332477441 | OPEL-L IVIEW MODULAR DRILL GUIDE |
| 07640332477298 | OPEL-L IVIEW PLATE ASSEMBLY, L42 |
| 07640332477274 | OPEL-L IVIEW PLATE ASSEMBLY, L40 |
| 07640332477205 | OPEL-L PLATE ASSEMBLY, L42 |
| 07640332477199 | OPEL-L PLATE ASSEMBLY, L40 |