TFN-ADVANCE 04037224S

GUDID H67904037224S0

12MM/125 DEG TI CANN TFNA 340MM/RIGHT - STERILE

Synthes GmbH

Femur nail, sterile
Primary Device IDH67904037224S0
NIH Device Record Keyc847be20-ef84-4df1-bacc-655a4a1b53b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameTFN-ADVANCE
Version Model Number04.037.224S
Catalog Number04037224S
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 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
GS110886982097101 [Primary]
HIBCCH67904037224S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


[H67904037224S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-04-28
Device Publish Date2015-09-14

On-Brand Devices [TFN-ADVANCE]

H67904038400S0TFNA FENESTRATED HELICAL BLADE 100MM - STERILE
H679040384000TFNA FENESTRATED HELICAL BLADE 100MM
H67904038395S0TFNA FENESTRATED HELICAL BLADE 95MM - STERILE
H679040383950TFNA FENESTRATED HELICAL BLADE 95MM
H67904038390S0TFNA FENESTRATED HELICAL BLADE 90MM - STERILE
H679040383900TFNA FENESTRATED HELICAL BLADE 90MM
H67904038385S0TFNA FENESTRATED HELICAL BLADE 85MM - STERILE
H679040383850TFNA FENESTRATED HELICAL BLADE 85MM
H67904038380S0TFNA FENESTRATED HELICAL BLADE 80MM - STERILE
H679040383800TFNA FENESTRATED HELICAL BLADE 80MM
H67904038375S0TFNA FENESTRATED HELICAL BLADE 75MM - STERILE
H679040383750TFNA FENESTRATED HELICAL BLADE 75MM
H67904038370S0TFNA FENESTRATED HELICAL BLADE 70MM - STERILE
H679040383700TFNA FENESTRATED HELICAL BLADE 70MM
H67904038330S0TFNA HELICAL BLADE 130MM STERILE
H679040383300TFNA HELICAL BLADE 130MM
H67904038325S0TFNA HELICAL BLADE 125MM STERILE
H679040383250TFNA HELICAL BLADE 125MM
H67904038320S0TFNA HELICAL BLADE 120MM STERILE
H679040383200TFNA HELICAL BLADE 120MM
H67904038315S0TFNA HELICAL BLADE 115MM STERILE
H679040383150TFNA HELICAL BLADE 115MM
H67904038310S0TFNA HELICAL BLADE 110MM STERILE
H679040383100TFNA HELICAL BLADE 110MM
H67904038305S0TFNA HELICAL BLADE 105MM STERILE
H679040383050TFNA HELICAL BLADE 105MM
H67904038300S0TFNA HELICAL BLADE 100MM STERILE
H679040383000TFNA HELICAL BLADE 100MM
H67904038295S0TFNA HELICAL BLADE 95MM STERILE
H679040382950TFNA HELICAL BLADE 95MM
H67904038290S0TFNA HELICAL BLADE 90MM STERILE
H679040382900TFNA HELICAL BLADE 90MM
H67904038285S0TFNA HELICAL BLADE 85MM STERILE
H679040382850TFNA HELICAL BLADE 85MM
H67904038280S0TFNA HELICAL BLADE 80MM STERILE
H679040382800TFNA HELICAL BLADE 80MM
H67904038275S0TFNA HELICAL BLADE 75MM STERILE
H679040382750TFNA HELICAL BLADE 75MM
H67904038270S0TFNA HELICAL BLADE 70MM STERILE
H679040382700TFNA HELICAL BLADE 70MM
H67904038230S0TFNA FENESTRATED SCREW 130MM - STERILE
H679040382300TFNA FENESTRATED SCREW 130MM
H67904038225S0TFNA FENESTRATED SCREW 125MM - STERILE
H679040382250TFNA FENESTRATED SCREW 125MM
H67904038220S0TFNA FENESTRATED SCREW 120MM - STERILE
H679040382200TFNA FENESTRATED SCREW 120MM
H67904038215S0TFNA FENESTRATED SCREW 115MM - STERILE
H679040382150TFNA FENESTRATED SCREW 115MM
H67904038210S0TFNA FENESTRATED SCREW 110MM - STERILE
H679040382100TFNA FENESTRATED SCREW 110MM

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.