05001087

GUDID 07611819831568

ADAPTOR SCHRADER/SYNTHES

Synthes GmbH

Surgical power tool adaptor
Primary Device ID07611819831568
NIH Device Record Key93596324-0a60-4158-9906-f85ab17bdb05
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.001.087
Catalog Number05001087
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107611819831568 [Direct Marking]
GS110886982129086 [Primary]
HIBCCH679050010870 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBBMOTOR, DRILL, PNEUMATIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


[07611819831568]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-18
Device Publish Date2016-06-30

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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