46648S

GUDID H67946648S0

11MM TI SOLID FEMORAL NAIL 480MM-STERILE

SYNTHES (U.S.A.) LP

Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail Femur nail

• Primary Device ID: H67946648S0
• NIH Device Record Key: 5f981ea3-4d4d-4fae-abce-805d9030cc1f
• Commercial Distribution Discontinuation: 2018-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 466.48S
• Catalog Number: 46648S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982232847 [Primary]
HIBCC	H67946648S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923580

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[H67946648S0]

Moist Heat or Steam Sterilization

[H67946648S0]

Moist Heat or Steam Sterilization

[H67946648S0]

Moist Heat or Steam Sterilization

[H67946648S0]

Moist Heat or Steam Sterilization

[H67946648S0]

Moist Heat or Steam Sterilization

[H67946648S0]

Moist Heat or Steam Sterilization

[H67946648S0]

Moist Heat or Steam Sterilization

[H67946648S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-12-08
• Device Publish Date: 2015-09-14

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

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• H981042006140 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 28MM THREAD LENGTH
• H981042006150 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 30MM THREAD LENGTH
• H981042006160 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 32MM THREAD LENGTH
• H981042006170 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 34MM THREAD LENGTH
• H981042006180 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 36MM THREAD LENGTH
• H981042006190 - Axon: 2024-07-12 3.5MM TI CANCELLOUS AXON(TM) SCREW 38MM THREAD LENGTH