03311043

GUDID H679033110430

REDUCTION WIRE/2.0MM DIAMETER 400MM LONG

Synthes GmbH

Orthopaedic bone wire
Primary Device IDH679033110430
NIH Device Record Key7f52dbf8-4997-4ca4-82f5-d5c1656e28c0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.311.043
Catalog Number03311043
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

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
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
GS110886982078049 [Primary]
HIBCCH679033110430 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


[H679033110430]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-27
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

07612334226747 - NA2025-07-31 LID 2/3 SIZE STAINLESS STEEL
07612334227980 - NA2025-07-31 TRAY FOR OPERACE, 1 FROM 2
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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