04031030

GUDID H679040310300

5.0MM TI RECON SCREW W/T25 STARDRIVE 100MM

Synthes GmbH

Hip internal fixation system
Primary Device IDH679040310300
NIH Device Record Keya51a40d8-b4b8-40f8-9431-046eae53ff5e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.031.030
Catalog Number04031030
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982094100 [Primary]
HIBCCH679040310300 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


[H679040310300]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

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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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