| Primary Device ID | 08800076462847 |
| NIH Device Record Key | 09ae392a-b350-40fb-a38b-c59b0d0c36b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRU RATCHET DRIVER |
| Version Model Number | TDR-TX15 |
| Company DUNS | 694514760 |
| Company Name | Truabutment Korea Co.,Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800076462847 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
[08800076462847]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-02 |
| Device Publish Date | 2025-09-24 |
| 08800076462922 | TDR-NU37 |
| 08800076462915 | TDR-NU20 |
| 08800076462908 | TDR-NU15 |
| 08800076462793 | TDR-S1020 |
| 08800076462786 | TDR-S1015 |
| 08800076462779 | TDR-H12537 |
| 08800076462762 | TDR-H12520 |
| 08800076462755 | TDR-H12515 |
| 08800076462748 | TDR-H1237 |
| 08800076462731 | TDR-H1220 |
| 08800076462724 | TDR-H1215 |
| 08800076462717 | TDR-H1037 |
| 08800076462700 | TDR-H1020 |
| 08800076462694 | TDR-H1015 |
| 08800076462687 | TDR-H0937 |
| 08800076462670 | TDR-H0920 |
| 08800076462663 | TDR-H0915 |
| 08800076441743 | TDR-GM37 |
| 08800076441736 | TDR-GM20 |
| 08800076441729 | TDR-GM15 |
| 08800076462892 | TDR-UG37 |
| 08800076462885 | TDR-UG20 |
| 08800076462878 | TDR-UG15 |
| 08800076462861 | TDR-TX37 |
| 08800076462854 | TDR-TX20 |
| 08800076462847 | TDR-TX15 |
| 08800076462830 | TDR-S12537 |
| 08800076462823 | TDR-S12520 |
| 08800076462816 | TDR-S12515 |
| 08800076462809 | TDR-S1037 |