KYPHON Xpander II Inflatable Bone Tamp

GUDID 00763000025694

BONE TAMP KX103 10/3 XPANDER II IBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00763000025694
• NIH Device Record Key: 1fc2b97b-c58c-4921-95bf-fc48575dd74c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON Xpander II Inflatable Bone Tamp
• Version Model Number: KX103
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000025694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101864

FDA Product Code

• HXG: TAMP

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: 2019-01-07
• Device Publish Date: 2018-12-06

On-Brand Devices [KYPHON Xpander II Inflatable Bone Tamp]

• 00763000025731: BONE TAMP KX203 20/3 XPANDER II IBT
• 00763000025717: BONE TAMP KX153 15/3 XPANDER II IBT
• 00763000025694: BONE TAMP KX103 10/3 XPANDER II IBT