| Primary Device ID | 08800076474505 |
| NIH Device Record Key | 3f560e9f-a179-4171-a121-8a0a88894dee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tru Driver Handpiece |
| Version Model Number | TDHP-H13515 |
| 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 | 08800076474505 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
[08800076474505]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-11 |
| Device Publish Date | 2025-12-03 |
| 08800076474550 | TDHP-ASCL |
| 08800076474543 | TDHP-ASCM |
| 08800076474536 | TDHP-ASCS |
| 08800076474512 | TDHP-H13520 |
| 08800076474505 | TDHP-H13515 |
| 08800076474499 | TDHP-H13510 |