| Primary Device ID | 08800076464483 |
| NIH Device Record Key | dd2de4f3-1f67-425f-898d-a8231bf13953 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruDriver Handpiece |
| Version Model Number | TDH-US |
| 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 | 08800076464483 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
Moist Heat or Steam Sterilization
[08800076464483]
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 |
| 08800076464551 | TDH-NUL |
| 08800076464544 | TDH-NUS |
| 08800076464537 | TDH-GML |
| 08800076464520 | TDH-GMS |
| 08800076464513 | TDH-TL |
| 08800076464506 | TDH-TS |
| 08800076464490 | TDH-UL |
| 08800076464483 | TDH-US |
| 08800076464476 | TDH-S125L |
| 08800076464469 | TDH-S125S |
| 08800076464452 | TDH-H12L |
| 08800076464445 | TDH-H12S |
| 08800076464438 | TDH-H09L |
| 08800076464421 | TDH-H09S |