03111042

GUDID H679031110420

15MM REDUCTION REAMING GUIDE F/VAL INTERCARPAL FUSION PL

Synthes GmbH

Orthopaedic reamer guide
Primary Device IDH679031110420
NIH Device Record Key0725f96a-e897-45d1-a81a-f8b75f7d81d2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.111.042
Catalog Number03111042
Company DUNS486711679
Company NameSynthes GmbH
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982072405 [Primary]
HIBCCH679031110420 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

Moist Heat or Steam Sterilization


[H679031110420]

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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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
10886982348180 - NA2025-06-27 5.0MM BLUNTED POINT SCHANZ SCREW 50MM THRD/250MM/HA STER
10886982348197 - NA2025-06-27 6.0MM BLUNTED POINT SCHANZ SCREW 45MM THRD/175MM/HA STER

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