237106S

GUDID H679237106S0

4.5MM 90 DEG CANN LC-ANGLED BLADE PLATE 10 HOLES/60MM-STER

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable
Primary Device IDH679237106S0
NIH Device Record Keyc6ed0292-97ba-4e9c-834b-9816368a186d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number237.106S
Catalog Number237106S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 Datetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982161024 [Primary]
HIBCCH679237106S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


[H679237106S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-09-18
Device Publish Date2015-09-14

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H6792042280 - NA2024-07-24 3.5MM SHAFT SCREW 28MM
H6792042320 - NA2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

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