389479

GUDID 07611819753129

ALIGNMENT TOOL

Synthes GmbH

Orthopaedic fixation implant alignment tool
Primary Device ID07611819753129
NIH Device Record Keyf92396fe-c749-4255-a5ca-810ac448e644
Commercial Distribution StatusIn Commercial Distribution
Version Model Number389.479
Catalog Number389479
Company DUNS486711679
Company NameSynthes GmbH
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

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819753129 [Direct Marking]
GS110705034775852 [Primary]
HIBCCH9813894790 [Secondary]

FDA Product Code

HXQCRIMPER, PIN

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


[07611819753129]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-04-27
Device Publish Date2016-12-31

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07612334228352 - NA2025-07-31 TRAY FOR OPERACE, 2 FROM 2
10886982348982 - NA2025-07-24 Ø12.8MM HOLLOW REAMER
10886982349835 - NA2025-07-24 WRENCH / 11MM SLOTTED SOCKET
10886982350121 - NA2025-07-24 FEMORAL GONIOMETER
10886982350152 - NA2025-07-24 5TH MET WIRE GUIDE
10886982350428 - NA2025-07-24 TENS BENDING EXTRACTOR

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