Kypon Express Bone Filler Device

GUDID 00763000026868

BONE FILLER DEVICE F06A SIZE 2

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement dispenser

• Primary Device ID: 00763000026868
• NIH Device Record Key: e5ba819a-8032-4280-9580-e5e944db0e24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kypon Express Bone Filler Device
• Version Model Number: F06A
• 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: 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	00763000026868 [Primary]

FDA Product Code

• KIH: DISPENSER, CEMENT

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: 2018-11-28
• Device Publish Date: 2018-10-28

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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• 00199150026951 - Medtronic Reusable Instruments: 2025-08-19 HANDLE X0525002 RETRACTOR BLADE
• 00199150027651 - Medtronic Reusable Instruments: 2025-08-19 ADAPTER X5598045 BREAKOFF DRIVER
• 00763000880194 - n/a: 2025-08-19 AWL 7967082 U-JOINT
• 00763000884499 - n/a: 2025-08-19 GUIDE 7080903 FIXED DRILL GUIDE
• 00763000884505 - n/a: 2025-08-19 GUIDE 7080904 VARIABLE DRILL GUIDE
• 00763000884574 - n/a: 2025-08-19 AWL 7080911 FIXED ANGLE AWL