| Primary Device ID | 00810111220200 |
| NIH Device Record Key | 1fc56e74-901d-40c5-96fd-5ae437e2f21f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | cut guide, fulcrum, seeker |
| Version Model Number | 1405-2496 |
| 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 | 00810111220200 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
[00810111220200]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-20 |
| Device Publish Date | 2022-09-12 |
| 00810111220279 | all in one SS Right |
| 00810111220262 | all in one SS left |
| 00810111220231 | all in one |
| 00810111220224 | all in one |
| 00810111220217 | all in one |
| 00810111220200 | all in one |
| 00810111220194 | all in one SS right |
| 00810111220187 | all in one SS left |
| 00810111220538 | Mini 3 in 1 Left |
| 00810111220521 | Mini 3 in 1 Right |
| 00810111221665 | Mini 3 in 1 Right |
| 00810111221658 | Mini 3 in 1 Left |