KYPHON Xpander KyphoPak Tray

GUDID 00763000031657

KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00763000031657
• NIH Device Record Key: ec462141-2285-4dd3-87f3-34a8a9390a7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON Xpander KyphoPak Tray
• Version Model Number: KPT1002
• 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	00763000031657 [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 Xpander KyphoPak Tray]

• 00763000031794: KIT KPT2005 KYPAK TRY 20/3 FF W/ONE STEP
• 00763000031787: KIT KPT2004 KYPAK TRY 20/3 ADDL FRACTURE
• 00763000031770: KIT KPT2003 KYPAK TRY 20/3 FF W/ADV OIS
• 00763000031763: KIT KPT2002 KYPHOPAK TRAY 20/3 FF W/OIS
• 00763000031756: KIT KPT1505 KYPAK TRY 15/3 FF W/ONESTEP
• 00763000031749: KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE
• 00763000031732: KIT KPT1503 KYPAK TRY 15/3 FF W/ADV OIS
• 00763000031725: KIT KPT1502 KYPHOPAK TRAY 15/3 FF W/OIS
• 00763000031718: KIT KPT1004 KYPAK TRY 10/3 ADDL FRACTURE
• 00763000031701: KIT KPT1003 KYPAK TRAY 10/3 FFW/ADV OIS
• 00763000031664: KIT KPT1005 KYPAK TRY 10/3 FF W/ONESTEP
• 00763000031657: KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS