KYPHON Bone Biopsy Kit

GUDID 00763000025526

BONE BIOPSY F18A KYPHX BONE BIOPSY KIT

MEDTRONIC SOFAMOR DANEK, INC.

Bone access cannula

• Primary Device ID: 00763000025526
• NIH Device Record Key: 6cd760cf-f80a-4daa-9af6-482d5b910a1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON Bone Biopsy Kit
• Version Model Number: F18A
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000025526 [Primary]

FDA Product Code

• MJG: DEVICE, PERCUTANEOUS, BIOPSY

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: 2019-01-21
• Device Publish Date: 2018-12-21

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

• 00763000787844 - CD HORIZON® Spinal System: 2025-05-27 ROD 8672055 SEXTANT 55MM TI
• 00763000728335 - n/a: 2025-05-26 TRAY 981991001 ALOP RETRACTOR TRAY 1
• 00763000728366 - n/a: 2025-05-26 TRAY 981991004 ALOP RETRACTOR TRAY 4
• 00763000728373 - n/a: 2025-05-26 TRAY 981991005 ALOP RETRACTOR TRAY 5
• 00763000858407 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-26 SHANK 55901610200 ILIAC CN STER 11.5X100
• 00763000858414 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-26 SHANK 55901610210 ILIAC CN STER 11.5X110
• 00763000858421 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-26 SHANK 55901610280 ILIAC CAN STER 11.5X80
• 00763000858438 - CD Horizon™ ModuLeX™ Spinal System: 2025-05-26 SHANK 55901610290 ILIAC CAN STER 11.5X90