Cotton Trial

GUDID 00810111224154

TMC Cotton Trial, 8mm

Treace Medical Concepts, Inc.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID00810111224154
NIH Device Record Keybe436141-360c-4092-993f-931bc06a5347
Commercial Distribution StatusIn Commercial Distribution
Brand NameCotton Trial
Version Model Number02-00322
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
GS100810111224154 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

Moist Heat or Steam Sterilization


[00810111224154]

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 [Cotton Trial]

00810111224277TMC Cotton Trial, 10mm
00810111224154TMC Cotton Trial, 8mm
00810111224147TMC Cotton Trial, 6mm

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