KYPHON Express II KyphoPak Tray

GUDID 00763000026936

BONE TAMP KIT KEX152NB AF E2 15/2

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00763000026936
• NIH Device Record Key: bf1be1ae-c11e-4a24-bba9-2933b4441dad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON Express II KyphoPak Tray
• Version Model Number: KEX152NB
• 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: true
• 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

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	00763000026936 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123771

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: 2019-02-27
• Device Publish Date: 2019-01-27

On-Brand Devices [KYPHON Express II KyphoPak Tray]

• 00763000026967: BONE TAMP KIT KEX202NB AF E2 20/2
• 00763000026943: BONE TAMP KIT KEX202EB FF E2 20/2 OI
• 00763000026936: BONE TAMP KIT KEX152NB AF E2 15/2
• 00763000026912: BONE TAMP KIT KEX152EB FF E2 15/2 OI
• 00763000026905: BONE TAMP KIT KEX102NB AF E2 10/2
• 00763000026882: BONE TAMP KIT KEX102EB FF E2 10/2 OI