KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack

GUDID 00613994745552

BONE CEMENT C01B HV-R WITH MIXER US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-medicated

• Primary Device ID: 00613994745552
• NIH Device Record Key: a276a6ed-1012-4e06-9c6a-fc3207c86fa3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack
• Version Model Number: C01B
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00613994745552 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041584

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

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: 2015-09-01

On-Brand Devices [KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack]

• 00613994745569: BONE CEMENT C01B HV-R WITH MIXER CAN
• 00613994745552: BONE CEMENT C01B HV-R WITH MIXER US
• 00613994515155: BONE CEMENT C01B HV-R WITH MIXER US
• 00643169097834: BONE CEMENT C01B HV-R WITH MIXER US