| Primary Device ID | 08800000925561 |
| NIH Device Record Key | 1c66dca3-1817-466a-bac0-34bf38f566fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hiossen Prosthetic System |
| Version Model Number | ETHLAP7R |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800000925561 [Primary] |
| NHA | Abutment, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2015-10-16 |
| 08800000963327 | OAON01S |
| 08800000925608 | ETHLAP5M |
| 08800000925592 | ETHLAP7M |
| 08800000925585 | ETHLAP9M |
| 08800000925578 | ETHLAP5R |
| 08800000925561 | ETHLAP7R |
| 08800000925554 | ETHLAP9R |
| 08800000925547 | GSCHABSMT |
| 08800000925530 | GSCHABSST |
| 08800000925523 | HGNCA401MHW |
| 08800000925516 | HGNCA403MHW |
| 08800000925509 | HGNCA401MNW |
| 08800000925493 | HGNCA403MNW |
| 08800000925486 | HGNCA451SHW |
| 08800000925479 | HGNCA453SHW |
| 08800000925462 | HGNCA451SNW |
| 08800000925455 | HGNCA453SNW |
| 08800000925448 | ORN1C |
| 08800000925431 | ORN1R |
| 08800000925424 | ORN1 |
| 08800000925417 | MGR100TH |
| 08800000925400 | MGW100TH |
| 08800000925394 | MGR200TH |
| 08800000925387 | MGW200TH |
| 08809892359041 | MGW200TH |
| 08809892359027 | MGW100TH |
| 08809892359003 | MGR200TH |
| 08809892358983 | MGR100TH |