04168115S

GUDID 10886982274359

FEMORAL NECK SYSTEM IMPLANT KIT/ LENGTH 115MM STERILE

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID10886982274359
NIH Device Record Key0d75a217-2a0d-4c98-b4ee-11ecfe4d3dfe
Commercial Distribution StatusIn Commercial Distribution
Version Model Number04.168.115S
Catalog Number04168115S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
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
GS110886982274359 [Primary]

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

[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


[10886982274359]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-02-27
Device Publish Date2018-04-25

Devices Manufactured by SYNTHES (U.S.A.) LP

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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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