| Primary Device ID | B167S1110S001160 |
| NIH Device Record Key | 9ba13b71-6a11-4921-8a16-4bd231a7deae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CURE OPEL-C |
| Version Model Number | S1-11-0S001-16 |
| Company DUNS | 182698477 |
| Company Name | MEDITECH SPINE, LLC |
| 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 | false |
| 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 |