03632397

GUDID 07611819588936

22MM LARGE UNIVERSAL NAVIGATION INTERFACE

Synthes GmbH

Orthopaedic implant/instrument adaptor, reusable
Primary Device ID07611819588936
NIH Device Record Key7d5dace8-c4c4-46e7-b9f5-73db0078b89e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.632.397
Catalog Number03632397
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
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
GS107611819588936 [Direct Marking]
GS110705034719900 [Primary]
HIBCCH981036323970 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


[07611819588936]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-26
Device Publish Date2016-06-30

Devices Manufactured by Synthes GmbH

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
10886982348326 - NA2025-07-08 SCREW RACK 3.0 & 4.0
10887587078434 - NA2025-07-03 REDUCTION FORCEPS W/ POINTS
10886982343994 - NA2025-07-01 Ø14MM HOLLOW REAMER - FRN

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