InflateFX™ Gen II Fracture Management

GUDID 00643169110212

TOOLS AND FILLER EL153B LARGE KIT

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00643169110212
• NIH Device Record Key: 3bac5bd8-0466-4e87-aa30-89ee9d4bcf26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InflateFX™ Gen II Fracture Management
• Version Model Number: EL153B
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• 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: 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169110212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041454

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-09

On-Brand Devices [InflateFX™ Gen II Fracture Management]

• 00643169110212: TOOLS AND FILLER EL153B LARGE KIT
• 00643169021310: BONE TAMP E103A 10/3 A LA CARTE
• 00643169348240: TOOLKIT IFXG2B SCOOP
• 00643169157255: TOOLS AND FILLER ES103B SMALL KIT
• 00643169157248: TOOLS AND FILLER EL153B LARGE KIT