23762

GUDID H679237620

95 DEG CONDYLAR PLATE 16 HOLES/60MM/267MM

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDH679237620
NIH Device Record Keyf7b7314e-640e-4ae5-a2c3-f074582fabfb
Commercial Distribution StatusIn Commercial Distribution
Version Model Number237.62
Catalog Number23762
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
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
GS110886982161376 [Primary]
HIBCCH679237620 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

Moist Heat or Steam Sterilization


[H679237620]

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

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10887587078465 - NA2025-09-19 NONRETAINING SCREWDRIVER BLADE FOR 90DEG SCREWDRIVER
10886982349873 - NA2025-09-01 CANNULATED CIRCULAR REAMER 16MM
10886982349880 - NA2025-09-01 CANNULATED CIRCULAR REAMER 18MM
10886982349897 - NA2025-09-01 CANNULATED CIRCULAR REAMER 20MM
10886982349903 - NA2025-09-01 CANNULATED CIRCULAR REAMER 22MM

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