237103S

GUDID H679237103S0

4.5MM 90 DEG CANN LC-ANGLED BLADE PLATE 10 HOLES/30MM-STER

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable, sterile
Primary Device IDH679237103S0
NIH Device Record Keybfec5819-bb55-4df3-9450-7177d06c69f5
Commercial Distribution Discontinuation2019-05-25
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number237.103S
Catalog Number237103S
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
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982160997 [Primary]
HIBCCH679237103S0 [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

[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


[H679237103S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-27
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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