Threaded Handle

GUDID 00810111224161

TMC ALLOGRAFT THREADED HANDLE

Treace Medical Concepts, Inc.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID00810111224161
NIH Device Record Keybccddf4f-208b-4cb1-9406-4071c6e9bbfe
Commercial Distribution StatusIn Commercial Distribution
Brand NameThreaded Handle
Version Model Number02-00323
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
GS100810111224161 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


[00810111224161]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-27
Device Publish Date2025-03-19

Devices Manufactured by Treace Medical Concepts, Inc.

00810111224499 - Drill Guide2025-09-22 Drill Guide and Template
00810111223904 - Targeting Guide2025-09-04 Trajectory Guide
00810111223911 - Targeting Guide2025-09-04 Guide Targeter
00810111223928 - Targeting Guide2025-09-04 Guide Body
00810111223935 - Cut Guide2025-09-04 Cut Guide
00810111225076 - Drill Tack2025-09-04 2.9MM Tack
00810111223874 - K-wire Sleeve2025-09-03 4mm Short Sleeve
00810111223881 - K-wire Sleeve2025-09-03 3mm Long Sleeve

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