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GUDID 00810111221962

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Treace Medical Concepts, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable
Primary Device ID00810111221962
NIH Device Record Key8ca8bd78-86ca-4aac-aa0a-bdd92a61ff3a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePin Guide, Left
Version Model Number01-1000-021
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
GS100810111221962 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


[00810111221962]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-21
Device Publish Date2023-11-13

On-Brand Devices [Pin Guide, Left]

00810111221962Pin Guide, Left
00810111221948Pin Guide, Left
00810111221924Pin Guide, Left
00810111221900Pin Guide, Left
00810111221887Pin Guide, Left
00810111221863Pin Guide, Left

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