Retraction Drill Guide

GUDID 00810111222112

Retraction Drill Guide

Treace Medical Concepts, Inc.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID00810111222112
NIH Device Record Key3c66993a-1ca9-4d1f-b3c2-cf9be266fea7
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetraction Drill Guide
Version Model Number02-00125
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
GS100810111222112 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


[00810111222112]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

Devices Manufactured by Treace Medical Concepts, Inc.

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