| Primary Device ID | 08809917147431 |
| NIH Device Record Key | 9ac71453-e249-4a15-bea6-fdeb66bf42c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneJet SG |
| Version Model Number | OJSG-500 |
| Company DUNS | 963215286 |
| Company Name | Osstem Implant Co.,Ltd. |
| 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 | true |
| 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 |