05001182

GUDID 07611819414778

SAW ATTACHMENT/90 DEGREE ANGLED FOR EPD AND APD

Synthes GmbH

Sawing power tool attachment, sagittal
Primary Device ID07611819414778
NIH Device Record Keyb441ba2f-5044-4839-8aaf-69d4a94339a1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05.001.182
Catalog Number05001182
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
GS107611819414778 [Direct Marking]
GS110886982129550 [Primary]
HIBCCH679050011820 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBBMOTOR, DRILL, PNEUMATIC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

Moist Heat or Steam Sterilization


[07611819414778]

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

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
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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