| Primary Device ID | 08800000974842 |
| NIH Device Record Key | 0ee7f8d4-0502-4ddf-b32f-f11a4bc75a68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ET US SS Prosthetic system |
| Version Model Number | TMEW200 |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |