03312840

GUDID H679033128400

MAXFRAME(TM) RADIOGRAPHIC MARKER

Synthes GmbH

External orthopaedic fixation system, reusable
Primary Device IDH679033128400
NIH Device Record Keyef4379dd-9fe1-4d05-ab17-0c947445c7c6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.312.840
Catalog Number03312840
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS110886982260956 [Primary]
HIBCCH679033128400 [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

[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


[H679033128400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-05-02
Device Publish Date2017-04-19

Devices Manufactured by Synthes GmbH

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
10886982348326 - NA2025-07-08 SCREW RACK 3.0 & 4.0
10887587078434 - NA2025-07-03 REDUCTION FORCEPS W/ POINTS
10886982343994 - NA2025-07-01 Ø14MM HOLLOW REAMER - FRN

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