TFN-ADVANCE 04037916S

GUDID H67904037916S0

9MM/125 DEG TI CANN TFNA 260MM/RIGHT - STERILE

Synthes GmbH

Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail, sterile Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: H67904037916S0
• NIH Device Record Key: 3c6da492-ca1b-4099-8bce-4bbe571903bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TFN-ADVANCE
• Version Model Number: 04.037.916S
• Catalog Number: 04037916S
• 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
• 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	10886982097781 [Primary]
HIBCC	H67904037916S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131548

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

Moist Heat or Steam Sterilization

[H67904037916S0]

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: 2015-09-14

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