| Primary Device ID | 08800076418363 |
| NIH Device Record Key | 588be767-e98c-4790-9d8f-7150a1f805b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tru 2-way Driver |
| Version Model Number | TD2W-TXS125 |
| 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 | 08800076418363 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800076418363]
Moist Heat or Steam Sterilization
[08800076418363]
Moist Heat or Steam Sterilization
[08800076418363]
Moist Heat or Steam Sterilization
[08800076418363]
Moist Heat or Steam Sterilization
[08800076418363]
Moist Heat or Steam Sterilization
[08800076418363]
Moist Heat or Steam Sterilization
[08800076418363]
Moist Heat or Steam Sterilization
[08800076418363]
Moist Heat or Steam Sterilization
[08800076418363]
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 |
| 08800076418370 | TD2W-TXUG |
| 08800076462656 | TD2W-GM30T |
| 08800076431652 | TD2W-H09GM |
| 08800076418387 | TD2W-UGS125 |
| 08800076418363 | TD2W-TXS125 |
| 08800076418356 | TD2W-H12125 |
| 08800076418349 | TD2W-H09125 |