Anatomic Model

GUDID 00810111222389

Pre-Op Forefoot Anatomic Model

Treace Medical Concepts, Inc.

Custom-made organ/bone anatomy model
Primary Device ID00810111222389
NIH Device Record Key38c7c106-356e-4c6f-8397-b86a406c0e48
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnatomic Model
Version Model NumberPSI-89-1000-002
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810111222389 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


[00810111222389]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-27
Device Publish Date2023-11-17

Devices Manufactured by Treace Medical Concepts, Inc.

00810111223515 - SpeedMTP Compression Screws2024-11-14 Headless Compression Screws
00810111222693 - Ratchet Handle2024-11-08 Ratchet Handle
00810111222846 - Guide Sleeve2024-11-08 Screw Sleeve
00810111222853 - Guide Sleeve2024-11-08 Parallel Guide
00810111222860 - Elevator2024-11-08 Head Shifter
00810111222877 - Length Gage2024-11-08 Length Gage
00810111222990 - Drill2024-11-08 Drill, Cannulated
00810111223003 - Drill2024-11-08 Drill, Cannulated

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