Incision Guide

GUDID 00810111222075

Incision Guide, MTA

Treace Medical Concepts, Inc.

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Primary Device ID00810111222075
NIH Device Record Key9f4b70ab-ea2c-4be2-94a5-daa7c2c66898
Commercial Distribution StatusIn Commercial Distribution
Brand NameIncision Guide
Version Model Number02-00146
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
GS100810111222075 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


[00810111222075]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-29
Device Publish Date2023-12-21

On-Brand Devices [Incision Guide]

00810111220507Incision Guide
00810111222075Incision Guide, MTA

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