| Primary Device ID | 00810111222013 |
| NIH Device Record Key | 3098aca2-c233-434c-a9c5-f3f4bd9203bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Instrument Tray |
| Version Model Number | 01-8000 |
| 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 | 00810111222013 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
[00810111222013]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-01-30 |
| Device Publish Date | 2024-01-22 |
| 00853114006983 | Reamer Tray |
| 00853114006754 | Instrument Tray |
| 00853114006716 | Instrument Tray |
| 00810111220491 | Instrument Tray |
| 00810111220385 | Instrument Tray |
| 00810111221566 | Auxiliary Tray |
| 00810111222150 | Instrument Tray |
| 00810111221795 | Instrument Tray |
| 00810111222013 | Instrument Tray |
| 00810111223430 | Instrument Tray |
| 00810111223423 | Instrument Tray |
| 00810111223546 | Instrument Tray |
| 00810111224437 | TMC Allograft Trial Tray |
| 00810111222952 | Instrument Tray |
| 00810111224864 | Instrument Tray |