Cross Joint Pin Guide, Left

GUDID 00810111221825

Cross Joint Pin Guide, Left

Treace Medical Concepts, Inc.

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Primary Device ID00810111221825
NIH Device Record Key7f809d03-a6b5-4e62-bb2a-c366816cb36f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCross Joint Pin Guide, Left
Version Model Number01-1000-005
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
GS100810111221825 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

Moist Heat or Steam Sterilization


[00810111221825]

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

Devices Manufactured by Treace Medical Concepts, Inc.

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00810111222723 - TMC PSI Cut Guide System2024-03-19 Cut Guide
00810111222730 - TMC PSI Cut Guide System2024-03-19 Cut Guide
00810111222396 - Lapiplasty SpeedPlate2024-02-22 Rapid Compression Implants
00810111221849 - Derotation Pin Guide2024-02-13 Derotation Pin Guide
00810111222013 - Instrument Tray2024-01-30 Instrument Tray

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