TFN-ADVANCE 04038225S

GUDID H67904038225S0

TFNA FENESTRATED SCREW 125MM - STERILE

Synthes GmbH

Spiral blade

• Primary Device ID: H67904038225S0
• NIH Device Record Key: 6297a525-f1ba-45d1-8076-26bb10f88c0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TFN-ADVANCE
• Version Model Number: 04.038.225S
• Catalog Number: 04038225S
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982098870 [Primary]
HIBCC	H67904038225S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160167

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

[H67904038225S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-28
• Device Publish Date: 2017-10-06

On-Brand Devices [TFN-ADVANCE]

• H67904038400S0: TFNA FENESTRATED HELICAL BLADE 100MM - STERILE
• H679040384000: TFNA FENESTRATED HELICAL BLADE 100MM
• H67904038395S0: TFNA FENESTRATED HELICAL BLADE 95MM - STERILE
• H679040383950: TFNA FENESTRATED HELICAL BLADE 95MM
• H67904038390S0: TFNA FENESTRATED HELICAL BLADE 90MM - STERILE
• H679040383900: TFNA FENESTRATED HELICAL BLADE 90MM
• H67904038385S0: TFNA FENESTRATED HELICAL BLADE 85MM - STERILE
• H679040383850: TFNA FENESTRATED HELICAL BLADE 85MM
• H67904038380S0: TFNA FENESTRATED HELICAL BLADE 80MM - STERILE
• H679040383800: TFNA FENESTRATED HELICAL BLADE 80MM
• H67904038375S0: TFNA FENESTRATED HELICAL BLADE 75MM - STERILE
• H679040383750: TFNA FENESTRATED HELICAL BLADE 75MM
• H67904038370S0: TFNA FENESTRATED HELICAL BLADE 70MM - STERILE
• H679040383700: TFNA FENESTRATED HELICAL BLADE 70MM
• H67904038330S0: TFNA HELICAL BLADE 130MM STERILE
• H679040383300: TFNA HELICAL BLADE 130MM
• H67904038325S0: TFNA HELICAL BLADE 125MM STERILE
• H679040383250: TFNA HELICAL BLADE 125MM
• H67904038320S0: TFNA HELICAL BLADE 120MM STERILE
• H679040383200: TFNA HELICAL BLADE 120MM
• H67904038315S0: TFNA HELICAL BLADE 115MM STERILE
• H679040383150: TFNA HELICAL BLADE 115MM
• H67904038310S0: TFNA HELICAL BLADE 110MM STERILE
• H679040383100: TFNA HELICAL BLADE 110MM
• H67904038305S0: TFNA HELICAL BLADE 105MM STERILE
• H679040383050: TFNA HELICAL BLADE 105MM
• H67904038300S0: TFNA HELICAL BLADE 100MM STERILE
• H679040383000: TFNA HELICAL BLADE 100MM
• H67904038295S0: TFNA HELICAL BLADE 95MM STERILE
• H679040382950: TFNA HELICAL BLADE 95MM
• H67904038290S0: TFNA HELICAL BLADE 90MM STERILE
• H679040382900: TFNA HELICAL BLADE 90MM
• H67904038285S0: TFNA HELICAL BLADE 85MM STERILE
• H679040382850: TFNA HELICAL BLADE 85MM
• H67904038280S0: TFNA HELICAL BLADE 80MM STERILE
• H679040382800: TFNA HELICAL BLADE 80MM
• H67904038275S0: TFNA HELICAL BLADE 75MM STERILE
• H679040382750: TFNA HELICAL BLADE 75MM
• H67904038270S0: TFNA HELICAL BLADE 70MM STERILE
• H679040382700: TFNA HELICAL BLADE 70MM
• H67904038230S0: TFNA FENESTRATED SCREW 130MM - STERILE
• H679040382300: TFNA FENESTRATED SCREW 130MM
• H67904038225S0: TFNA FENESTRATED SCREW 125MM - STERILE
• H679040382250: TFNA FENESTRATED SCREW 125MM
• H67904038220S0: TFNA FENESTRATED SCREW 120MM - STERILE
• H679040382200: TFNA FENESTRATED SCREW 120MM
• H67904038215S0: TFNA FENESTRATED SCREW 115MM - STERILE
• H679040382150: TFNA FENESTRATED SCREW 115MM
• H67904038210S0: TFNA FENESTRATED SCREW 110MM - STERILE
• H679040382100: TFNA FENESTRATED SCREW 110MM