| Primary Device ID | 08800076417151 |
| NIH Device Record Key | 19b9927c-523d-4825-8701-73f4d2b503a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruGUIDE Twist Drill |
| Version Model Number | CG2-TD35L |
| 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 | 08800076417151 [Primary] |
| DZA | Drill, Dental, Intraoral |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800076417151]
Moist Heat or Steam Sterilization
[08800076417151]
Moist Heat or Steam Sterilization
[08800076417151]
Moist Heat or Steam Sterilization
[08800076417151]
Moist Heat or Steam Sterilization
[08800076417151]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-23 |
| Device Publish Date | 2025-12-15 |
| 08800076417199 | CG2-TD28E |
| 08800076417182 | CG2-TD22E |
| 08800076417144 | CG2-TD28L |
| 08800076417137 | CG2-TD22L |
| 08800076417090 | CG2-TD28M |
| 08800076417083 | CG2-TD22M |
| 08800076417038 | CG2-TD22S |
| 08800076417175 | CG2-TD45L |
| 08800076417168 | CG2-TD40L |
| 08800076417151 | CG2-TD35L |
| 08800076417120 | CG2-TD45M |
| 08800076417113 | CG2-TD40M |
| 08800076417106 | CG2-TD35M |
| 08800076417076 | CG2-TD45S |
| 08800076417069 | CG2-TD40S |
| 08800076417052 | CG2-TD35S |
| 08800076417045 | CG2-TD28S |