KYPHON ELEMENT™ Balloon Kyphoplasty System

GUDID 20643169842735

BONE FILLER 7480703T BFD SIZE 3

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser Orthopaedic cement dispenser

• Primary Device ID: 20643169842735
• NIH Device Record Key: aa116a9d-390f-4d86-9125-2d5f7bdf2fd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON ELEMENT™ Balloon Kyphoplasty System
• Version Model Number: 7480703T
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20643169842735 [Primary]

FDA Product Code

• KIH: DISPENSER, CEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-12
• Device Publish Date: 2023-06-03

On-Brand Devices [KYPHON ELEMENT™ Balloon Kyphoplasty System]

• 00643169582231: BONE ACCESS TOOLS T25R VALUE BONE ACCESS
• 00643169582248: BONE FILLER DEVICE F25R 3 VALUE BFD
• 20643169842735: BONE FILLER 7480703T BFD SIZE 3
• 00643169582224: INFLATION SYRINGE A25R VALUE SYRINGE