04031027

GUDID H679040310270

5.0MM TI RECON SCREW W/T25 STARDRIVE 85MM

Synthes GmbH

Hip internal fixation system
Primary Device IDH679040310270
NIH Device Record Keyd59e02a8-4798-40ea-be03-df11a5cc7621
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.031.027
Catalog Number04031027
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
GS110886982094049 [Primary]
HIBCCH679040310270 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

Moist Heat or Steam Sterilization


[H679040310270]

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

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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