| Primary Device ID | 00810111222945 |
| NIH Device Record Key | b16327c5-ac49-42fd-b7f8-3c7b9bc1980b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AO Driver Tip |
| Version Model Number | 02-00214 |
| Company DUNS | 054808082 |
| Company Name | Treace Medical Concepts, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810111222945 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
[00810111222945]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-12 |
| Device Publish Date | 2024-06-04 |
| 00853114006730 | AO Driver Cannulated |
| 00853114006662 | non-cannulated driver assembly |
| 00853114006648 | AO hexalobular tip cannulated |
| 00853114006631 | AO hexalobular tip cannulated |
| 00853114006624 | AO hexalobular tip |
| 00810111222945 | AO Driver tip |