KYPHON® ELEMENT™

GUDID 00643169582217

INFLATABLE BONE TAMP KR153 15MM VALUEIBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00643169582217
• NIH Device Record Key: 56698987-2da1-43c5-a945-0538f80b8cf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® ELEMENT™
• Version Model Number: KR153
• 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

• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter
• Outer Diameter: 3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169582217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151532

FDA Product Code

• HRX: ARTHROSCOPE

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: 2016-04-14

On-Brand Devices [KYPHON® ELEMENT™]

• 00643169582217: INFLATABLE BONE TAMP KR153 15MM VALUEIBT
• 00763000025823: INFLATABLE BONE TAMP KR153 15MM VALUEIBT