TFN-ADVANCE 04038015S

GUDID H67904038015S0

TI END CAP FOR TFNA 15MM EXTN - STERILE

SYNTHES (U.S.A.) LP

Bone nail end-cap

• Primary Device ID: H67904038015S0
• NIH Device Record Key: 52f38c6a-b92b-48fb-80ff-4844962737f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TFN-ADVANCE
• Version Model Number: 04.038.015S
• Catalog Number: 04038015S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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
• 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	10886982098375 [Primary]
HIBCC	H67904038015S0 [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

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

[H67904038015S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-04-07
• Device Publish Date: 2015-09-14

On-Brand Devices [TFN-ADVANCE]

• H67904038015S0: TI END CAP FOR TFNA 15MM EXTN - STERILE
• H67904038010S0: TI END CAP FOR TFNA 10MM EXTN - STERILE
• H67904038005S0: TI END CAP FOR TFNA 5MM EXTN - STERILE
• H67904038000S0: TI END CAP FOR TFNA 0MM EXTN - STERILE