| Primary Device ID | 08809917070012 |
| NIH Device Record Key | 7ea9adc9-326f-4d6a-b3a0-ac39a0e93e3e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 122 Taper Full KIT |
| Version Model Number | O122TPFK |
| Company DUNS | 689051793 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809917070012 [Primary] |
| NYE | Fixture Mount Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
[08809917070012]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-28 |
| Device Publish Date | 2024-08-20 |
| 08809917147349 | H122TPFK |
| 08800121766524 | O122TPFK |
| 08809917158833 | HK122TPFK |
| 08809917168481 | H122TPFK |
| 08809917070012 | O122TPFK |
| 08800271260286 | HK122TPFK |