| 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 |
| 00810111225489 - Instrument Tray | 2026-03-31 Forefoot Instrument Tray |
| 00810111226745 - Instrument Tray | 2026-03-31 VPCS Hindfoot Tray |
| 00810111227148 - K-Wire | 2026-03-31 K-Wire |
| 00810111225649 - Depth Gage | 2026-03-27 K-Wire Depth Gauge |
| 00810111225601 - Reamer | 2026-03-10 Barrel Reamer |
| 00810111225618 - Reamer | 2026-03-10 Barrel Reamer |
| 00810111225625 - Reamer | 2026-03-10 Barrel Reamer |
| 00810111226691 - Positioner / Compressor | 2026-03-02 LIGHTNING BLOCK - PROXIMAL LEFT |