| Primary Device ID | 08800271249663 |
| NIH Device Record Key | 941deb7e-f104-4f31-96cb-958f7ee074ca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneGuide TS Implant Driver |
| Version Model Number | HOGFDRH57 |
| 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 | false |
| 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 | 08800271249663 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
[08800271249663]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-05-06 |
| Device Publish Date | 2025-04-28 |
| 08809917109170 | OGFDR57 |
| 08809917109163 | OGFDR50 |
| 08809917109125 | OGFDM50 |
| 08800271233990 | HOGIDHSR57 |
| 08800271233983 | HOGIDHSM57 |
| 08800271234218 | OGIDHSR57 |
| 08800271234201 | OGIDHSM57 |
| 08800271249663 | HOGFDRH57 |
| 08800271249649 | HOGFDRH50 |
| 08800271249625 | HOGFDMH50 |