240019

GUDID H6792400190

3.5MM/4.5MM WASHER

Synthes GmbH

Orthopaedic bone washer, non-sterile
Primary Device IDH6792400190
NIH Device Record Key47d94d03-02fe-45b1-872b-0e45068c9e53
Commercial Distribution StatusIn Commercial Distribution
Version Model Number240.019
Catalog Number240019
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 Usetrue
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
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982164407 [Primary]
HIBCCH6792400190 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


[H6792400190]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-29
Device Publish Date2015-09-14

Devices Manufactured by Synthes GmbH

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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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