390007

GUDID H6793900070

LARGE EX-FIX TUBE-TUBE CLAMP MR-CONDITIONAL

Synthes GmbH

External orthopaedic fixation system reprocessed component
Primary Device IDH6793900070
NIH Device Record Key918f5494-7c4c-4907-b7e7-bf35a120ecd8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number390.007
Catalog Number390007
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
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
GS107611819760585 [Direct Marking]
GS110886982197849 [Primary]
HIBCCH6793900070 [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

[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


[H6793900070]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-05-02
Device Publish Date2015-09-14

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07611819642669 - NA2025-06-27 130 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
07611819642676 - NA2025-06-27 125 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
07611819655522 - NA2025-06-27 135 DEG AIMING ARM STATIC+DYNAMIC DISTAL LOCKING
10886982348159 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER
10886982348166 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/250MM/HA STER
10886982348173 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/175MM/HA STER

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