Osteotome

GUDID 00810111220606

Hooked Osteotome

Treace Medical Concepts, Inc.

Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome Orthopaedic osteotome
Primary Device ID00810111220606
NIH Device Record Key4e1bce87-b6c7-4b6b-a268-2e554688a6c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteotome
Version Model Number1405-2626
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 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
GS100810111220606 [Primary]

FDA Product Code

HWMOsteotome

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111220606]

Moist Heat or Steam Sterilization


[00810111220606]

Moist Heat or Steam Sterilization


[00810111220606]

Moist Heat or Steam Sterilization


[00810111220606]

Moist Heat or Steam Sterilization


[00810111220606]

Moist Heat or Steam Sterilization


[00810111220606]

Moist Heat or Steam Sterilization


[00810111220606]

Moist Heat or Steam Sterilization


[00810111220606]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30

On-Brand Devices [Osteotome]

00853114006334TriTome™ Triple-Edge Release Instrument
00810111221009Osteotome
00810111220910Osteotome
00810111220903Osteotome
00810111220606Hooked Osteotome
00810111220590Straight Osteotome
00810111221641Hooked Osteotome
00810111221634Square Osteotome

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.