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.

00810111225137 - Elevator2025-10-03 Elevator
00810111225106 - Percuplasty Tray2025-10-01Instrument Tray
00810111225106 - Percuplasty Tray2025-10-01 Instrument Tray
00810111225144 - Rasp2025-10-01 Rasp
00810111224499 - Drill Guide2025-09-22 Drill Guide and Template
00810111223904 - Targeting Guide2025-09-04 Trajectory Guide
00810111223911 - Targeting Guide2025-09-04 Guide Targeter
00810111223928 - Targeting Guide2025-09-04 Guide Body
00810111223935 - Cut Guide2025-09-04 Cut Guide

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