KYPHON Express KyphoPak Tray

GUDID 00763000031817

KIT KPE1002 KYPAK EXPRESS TRAY 10/2 AF

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00763000031817
• NIH Device Record Key: 3f0e0133-09dc-4203-8107-fc36fdc5945f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON Express KyphoPak Tray
• Version Model Number: KPE1002
• 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, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000031817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041454

FDA Product Code

• HRX: Arthroscope

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: 2019-02-26
• Device Publish Date: 2019-01-26

On-Brand Devices [KYPHON Express KyphoPak Tray]

• 00763000031831: KIT KPE1004 KPHOPAK EXPRESS TRAY 15/2 AF
• 00763000031824: KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS
• 00763000031817: KIT KPE1002 KYPAK EXPRESS TRAY 10/2 AF
• 00763000031800: KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS