| Primary Device ID | 00810111224116 |
| NIH Device Record Key | 1a6a163e-7218-46a4-9a12-d5fe7c5a730d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Evans Trial |
| Version Model Number | 02-00316 |
| 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 | 00810111224116 [Primary] |
| HWT | Template |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
[00810111224116]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-27 |
| Device Publish Date | 2025-03-19 |
| 00810111224253 | TMC Evans Trial, 12mm |
| 00810111224116 | TMC Evans Trial, 10mm |
| 00810111224109 | TMC Evans Trial, 8mm |
| 00810111224093 | TMC Evans Trial, 6mm |