474338S

GUDID H679474338S0

13MM TI CANNULATED FEMORAL NAIL 380MM-STERILE

SYNTHES (U.S.A.) LP

Femur nail
Primary Device IDH679474338S0
NIH Device Record Key5f770d14-d56e-4cda-b6e1-1673cd60032a
Commercial Distribution Discontinuation2019-09-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number474.338S
Catalog Number474338S
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982233776 [Primary]
HIBCCH679474338S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H679474338S0]

Moist Heat or Steam Sterilization


[H679474338S0]

Moist Heat or Steam Sterilization


[H679474338S0]

Moist Heat or Steam Sterilization


[H679474338S0]

Moist Heat or Steam Sterilization


[H679474338S0]

Moist Heat or Steam Sterilization


[H679474338S0]

Moist Heat or Steam Sterilization


[H679474338S0]

Moist Heat or Steam Sterilization


[H679474338S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2022-12-08
Device Publish Date2015-09-14

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

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H9812982060 - NA2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
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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