Cut Guide

GUDID 00810111222662

Single Slot Cut Guide

Treace Medical Concepts, Inc.

Osteotomy guide, reusable
Primary Device ID00810111222662
NIH Device Record Keya2346f0e-403a-4ba1-a7ab-d4bd5159b6ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameCut Guide
Version Model Number02-00151
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
GS100810111222662 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


[00810111222662]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-29
Device Publish Date2024-04-19

On-Brand Devices [Cut Guide]

00853114006990lesser TMT cut guide
00853114006976lesser TMT cut guide
00853114006846Cut Guide - platinum
00853114006839MIS cut guide - gold
00853114006822cut guide low angle (short)
00853114006815cut guide low angle - gold
00853114006761cut guide
00853114006563rotational cut guide
00853114006549cut guide
00853114006532cut guide
00810111221368lesser TMT cut guide
00810111221351lesser TMT cut guide
00810111221122Cut Guide
00810111221115Cut Guide
00810111221108Cut Guide
00810111220484Low pro cut guide
00810111220477low pro cut guide
00810111220460low pro cut guide
00810111220453low pro cut guide
00810111220446low pro cut guide
00810111220439low pro cut guide
00810111220422low pro cut guide
00810111220415cut guide - double
00810111220361cut guide
00810111220347lesser TMT cut guide medium
00810111220330lesser TMT cut guide large
00810111220323lesser TMT cut guide medium
00810111220316lesser TMT cut guide small
00810111220255cut guide
00810111220583Cut Guide
00810111222068MTA Stepped Cut Guide
00810111222051MTA Stepped Cut Guide
00810111222815STEPPED INLINE CUT GUIDE, LARGE
00810111222808STEPPED INLINE CUT GUIDE, MEDIUM
00810111222792STEPPED INLINE CUT GUIDE, SMALL
00810111222778Cut Guide
00810111222662Single Slot Cut Guide

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