03033003

GUDID 07612334121790

RADIOLUCENT AIMING ARM/FRN GREATER TROCHANTER

Synthes GmbH

Orthopaedic implant aiming arm
Primary Device ID07612334121790
NIH Device Record Key7c361018-53b1-4d2a-84f3-71cc9e01266e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.033.003
Catalog Number03033003
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
GS107612334121790 [Direct Marking]
GS110886982271075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


[07612334121790]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-05-02
Device Publish Date2018-01-11

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10886982349880 - NA2025-09-01 CANNULATED CIRCULAR REAMER 18MM
10886982349897 - NA2025-09-01 CANNULATED CIRCULAR REAMER 20MM
10886982349903 - NA2025-09-01 CANNULATED CIRCULAR REAMER 22MM
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

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