| Primary Device ID | 08800000970912 |
| NIH Device Record Key | 4bc0ee3b-83a4-4f30-9bbb-1958455cddc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSTEM Implant System - Abutment |
| Version Model Number | GSTA5420NWH |
| 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 |