Guide Sleeve

GUDID 00810111221702

Guide Sleeve

Treace Medical Concepts, Inc.

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable
Primary Device ID00810111221702
NIH Device Record Keyb93b8e9b-9be2-4073-9dca-3e7ddbc70fa9
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide Sleeve
Version Model Number02-00100
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
GS100810111221702 [Primary]

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


[00810111221702]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-07
Device Publish Date2023-08-30

On-Brand Devices [Guide Sleeve]

00810111221702Guide Sleeve
00810111221696Guide Sleeve

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