| Primary Device ID | 00810111222693 |
| NIH Device Record Key | 93c1672c-a71a-4b46-babb-f91e984a5b99 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ratchet Handle |
| Version Model Number | 02-00176 |
| 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 | 00810111222693 [Primary] |
| HXX | Screwdriver |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
[00810111222693]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-08 |
| Device Publish Date | 2024-10-31 |
| 00853114006747 | Cannulated Ratchet Handle |
| 00810111222693 | Ratchet Handle |