05001091

GUDID 07611819831605

SEAL NIPPLE F/DOUBLE AIR HOSE FOR AIR PEN DRIVE

Synthes GmbH

Surgical power tool adaptor
Primary Device ID07611819831605
NIH Device Record Keyf3964174-67fc-4737-a5ea-18394ea09282
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.001.091
Catalog Number05001091
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
GS107611819831605 [Direct Marking]
GS110886982129123 [Primary]
HIBCCH679050010910 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBBMOTOR, DRILL, PNEUMATIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

Moist Heat or Steam Sterilization


[07611819831605]

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

10886982350039 - NA2025-08-15 CRE DRILL GUIDE 15MM
10886982350046 - NA2025-08-15 CRE DRILL GUIDE 18MM
10886982350053 - NA2025-08-15 CRE DRILL GUIDE 20MM
10886982350060 - NA2025-08-15 CRE DRILL GUIDE 25MM
10886982350077 - NA2025-08-15 7.0MM CAN TAP LARGE QUICK COUPLING
07612334226747 - NA2025-07-31 LID 2/3 SIZE STAINLESS STEEL
07612334227980 - NA2025-07-31 TRAY FOR OPERACE, 1 FROM 2
07612334228352 - NA2025-07-31 TRAY FOR OPERACE, 2 FROM 2

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