Evans Trial

GUDID 00810111224116

TMC Evans Trial, 10mm

Treace Medical Concepts, Inc.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID00810111224116
NIH Device Record Key1a6a163e-7218-46a4-9a12-d5fe7c5a730d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvans Trial
Version Model Number02-00316
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
GS100810111224116 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


[00810111224116]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-27
Device Publish Date2025-03-19

On-Brand Devices [Evans Trial]

00810111224253TMC Evans Trial, 12mm
00810111224116TMC Evans Trial, 10mm
00810111224109TMC Evans Trial, 8mm
00810111224093TMC Evans Trial, 6mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.