Lapidus Trial

GUDID 00810111224079

TMC Lapidus Trial, 5mm

Treace Medical Concepts, Inc.

Surgical implant/trial-implant/sizer holder, reusable
Primary Device ID00810111224079
NIH Device Record Key163d86d1-6dae-4b62-90dc-ba990403edb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameLapidus Trial
Version Model Number02-00311
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
GS100810111224079 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

Moist Heat or Steam Sterilization


[00810111224079]

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

On-Brand Devices [Lapidus Trial]

00810111224086TMC Lapidus Trial, 9mm
00810111224079TMC Lapidus Trial, 5mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.