| Primary Device ID | 08800076417366 |
| NIH Device Record Key | a6783d52-95f9-4f0d-89fd-0d1c99e890f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruDriver Handle |
| Version Model Number | TDH-H1020 |
| 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 | 08800076417366 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800076417366]
Moist Heat or Steam Sterilization
[08800076417366]
Moist Heat or Steam Sterilization
[08800076417366]
Moist Heat or Steam Sterilization
[08800076417366]
Moist Heat or Steam Sterilization
[08800076417366]
Moist Heat or Steam Sterilization
[08800076417366]
Moist Heat or Steam Sterilization
[08800076417366]
Moist Heat or Steam Sterilization
[08800076417366]
Moist Heat or Steam Sterilization
[08800076417366]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-01 |
| Device Publish Date | 2025-09-23 |
| 08800076417588 | TDH-UG37 |
| 08800076417571 | TDH-UG20 |
| 08800076417564 | TDH-UG15 |
| 08800076417557 | TDH-TX37 |
| 08800076417540 | TDH-TX20 |
| 08800076417533 | TDH-TX15 |
| 08800076417526 | TDH-S12537 |
| 08800076417519 | TDH-S12520 |
| 08800076417502 | TDH-S12515 |
| 08800076417496 | TDH-S1037 |
| 08800076417489 | TDH-S1020 |
| 08800076417472 | TDH-S1015 |
| 08800076417465 | TDH-NU37 |
| 08800076417458 | TDH-NU20 |
| 08800076417441 | TDH-NU15 |
| 08800076417434 | TDH-H12537 |
| 08800076417427 | TDH-H12520 |
| 08800076417410 | TDH-H12515 |
| 08800076417403 | TDH-H1237 |
| 08800076417397 | TDH-H1220 |
| 08800076417380 | TDH-H1215 |
| 08800076417373 | TDH-H1037 |
| 08800076417366 | TDH-H1020 |
| 08800076417359 | TDH-H1015 |
| 08800076417342 | TDH-H0937 |
| 08800076417335 | TDH-H0920 |