KYPHON Express II Inflatable Bone Tamp

GUDID 00763000312053

BONE TAMP KE202 20/2 EXPRESS II IBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00763000312053
• NIH Device Record Key: cda5d242-1bac-46b7-b8ab-858e9e257e30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON Express II Inflatable Bone Tamp
• Version Model Number: KE202
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• 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
• 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
• 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
• 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
• 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
• 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
• 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	00763000312053 [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: 2020-11-02
• Device Publish Date: 2020-10-25

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

• 00763000025670: BONE TAMP KE202 20/2 EXPRESS II IBT
• 00763000025656: BONE TAMP KE152 15/2 EXPRESS II IBT
• 00763000025632: BONE TAMP KE102 10/2 EXPRESS II IBT
• 00763000312039: BONE TAMP KE152 15/2 EXPRESS II IBT
• 00763000312053: BONE TAMP KE202 20/2 EXPRESS II IBT