| Primary Device ID | 00810111225106 |
| NIH Device Record Key | 8310b710-0bcf-40f2-bf97-909b803335a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Percuplasty Tray |
| Version Model Number | 02-00458 |
| 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 | 00810111225106 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810111225106]
Moist Heat or Steam Sterilization
[00810111225106]
Moist Heat or Steam Sterilization
[00810111225106]
Moist Heat or Steam Sterilization
[00810111225106]
Moist Heat or Steam Sterilization
[00810111225106]
Moist Heat or Steam Sterilization
[00810111225106]
Moist Heat or Steam Sterilization
[00810111225106]
Moist Heat or Steam Sterilization
[00810111225106]
Moist Heat or Steam Sterilization
[00810111225106]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-10-01 |
| Device Publish Date | 2025-09-23 |
| 00810111225137 - Elevator | 2025-10-03 Elevator |
| 00810111225106 - Percuplasty Tray | 2025-10-01Instrument Tray |
| 00810111225106 - Percuplasty Tray | 2025-10-01 Instrument Tray |
| 00810111225144 - Rasp | 2025-10-01 Rasp |
| 00810111224499 - Drill Guide | 2025-09-22 Drill Guide and Template |
| 00810111223904 - Targeting Guide | 2025-09-04 Trajectory Guide |
| 00810111223911 - Targeting Guide | 2025-09-04 Guide Targeter |
| 00810111223928 - Targeting Guide | 2025-09-04 Guide Body |
| 00810111223935 - Cut Guide | 2025-09-04 Cut Guide |