05001099

GUDID 07611819170766

MAINTENANCE STATION FOR ELECTRIC PEN DRIVE

Synthes GmbH

Surgical power tool maintenance unit
Primary Device ID07611819170766
NIH Device Record Keyc2a271bf-ead7-434e-ae33-0f8396bddb77
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.001.099
Catalog Number05001099
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
GS107611819170766 [Direct Marking]
GS110886982129215 [Primary]
HIBCCH679050010990 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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10886982348333 - NA2025-02-26 1.1MM PARALLEL WIRE GUIDE
10886982348364 - NA2025-02-26 1.4MM PARALLEL WIRE GUIDE
10886982348395 - NA2025-02-26 1.6MM PARALLEL WIRE GUIDE
10886982349088 - NA2025-02-26 TERMITE REDUCTION FORCEPS SERRATED JAW
H6792050550 - NA2025-02-20 3.5MM CANNULATED SCREW PARTIALLY THREADED/55MM
H6794089050 - NA2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM

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