KYPHON® Osteo Introducer® System and BFD

GUDID 00763000557713

IBT KIT KPX153RB-A FF X2 15/3 OIS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00763000557713
• NIH Device Record Key: b3b9e38e-e77b-4a09-a3ef-1219f99ade6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® Osteo Introducer® System and BFD
• Version Model Number: KPX153RB-A
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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
• 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 dry place
• 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
• 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
• 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
• 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	00763000557713 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101864

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: 2021-08-17
• Device Publish Date: 2021-08-09

On-Brand Devices [KYPHON® Osteo Introducer® System and BFD]

• 00763000557744: IBT KIT KPX203RB-A FF X2 20/3 OIS
• 00763000557713: IBT KIT KPX153RB-A FF X2 15/3 OIS
• 00763000557683: IBT KIT KPX103RB-A FF X2 10/3 OIS