Percuplasty Tray

GUDID 00810111225106

Instrument Tray

Treace Medical Concepts, Inc.

Instrument tray, reusable
Primary Device ID00810111225106
NIH Device Record Key8310b710-0bcf-40f2-bf97-909b803335a6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePercuplasty Tray
Version Model Number02-00458
Company DUNS054808082
Company NameTreace Medical Concepts, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111225106 [Primary]

FDA Product Code

FSMTray, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-01
Device Publish Date2025-09-23

Devices Manufactured by Treace Medical Concepts, Inc.

00810111225489 - Instrument Tray2026-03-31 Forefoot Instrument Tray
00810111226745 - Instrument Tray2026-03-31 VPCS Hindfoot Tray
00810111227148 - K-Wire2026-03-31 K-Wire
00810111225649 - Depth Gage2026-03-27 K-Wire Depth Gauge
00810111225601 - Reamer2026-03-10 Barrel Reamer
00810111225618 - Reamer2026-03-10 Barrel Reamer
00810111225625 - Reamer2026-03-10 Barrel Reamer
00810111226691 - Positioner / Compressor2026-03-02 LIGHTNING BLOCK - PROXIMAL LEFT

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