| Primary Device ID | 08800209326596 |
| NIH Device Record Key | 17574b33-c5b8-4c4e-9900-0e19cd16a0b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSTEM Implant System |
| Version Model Number | TS3S4508S |
| Company DUNS | 689051793 |
| Company Name | Osstem Implant Co., Ltd. |
| 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 | 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 |