| Primary Device ID | 08800000995830 |
| NIH Device Record Key | f8b1f94b-9182-4b53-ba84-e5a8a68a447a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSSTEM IMPLANT CO., LTD. CHAIR BUSINESS |
| Version Model Number | HYMIX |
| Company DUNS | 695235881 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800000995830 [Primary] |
| EFD | Amalgamator, Dental, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-08 |
| Device Publish Date | 2022-10-31 |
| 08800000995724 | A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed |
| 08800000995052 | A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed |
| 08800000995045 | A unit that provides the media necessary for normal dental treatment procedures, e.g. compressed |
| 08800000995830 | HYMIX |