| Primary Device ID | 04250203940634 |
| NIH Device Record Key | 4e0f3e96-4fce-4951-a08e-1c9e9a1b9e4a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smart Kit OnePedicle 16/16 |
| Version Model Number | US7NA1110 |
| Company DUNS | 342087108 |
| Company Name | Joline GmbH & Co. KG |
| 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 | true |
| 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 |