Depth gauge countersink

GUDID 00810111223416

Depth gauge countersink

Treace Medical Concepts, Inc.

Surgical countersink, reusable
Primary Device ID00810111223416
NIH Device Record Keycd231e6b-eb2f-4768-b4c9-848681239dc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDepth gauge countersink
Version Model Number02-00246
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
GS100810111223416 [Primary]

FDA Product Code

HWWCountersink

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


[00810111223416]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-27
Device Publish Date2024-11-19

Devices Manufactured by Treace Medical Concepts, Inc.

00810111224512 - Saw Blade2025-05-16 FeatherRasp - ZMS
00810111224482 - Scalpel 2025-05-14 MTP Release Instrument
00810111224505 - Saw Blade2025-05-14 FeatherRasp - SM
00810111224321 - Reamer2025-05-02 18mm cup reamer
00810111224338 - Reamer2025-05-02 18mm cone reamer
00810111224345 - Reamer2025-05-02 21mm cup reamer
00810111224352 - Reamer2025-05-02 21mm cone reamer
00810111224369 - Reamer2025-05-02 23mm cup reamer

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