MAGNIFUSE® II Bone Graft

GUDID 00643169216242

DBM 7509510 MAGNIFUSE II 2.5 CM X 10 CM

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived Bone matrix implant, human-derived

• Primary Device ID: 00643169216242
• NIH Device Record Key: 617e902c-7525-4912-bc91-9be21cb1d3c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGNIFUSE® II Bone Graft
• Version Model Number: 7509510
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169216242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122513

FDA Product Code

• MQV: FILLER, BONE VOID, CALCIUM COMPOUND

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-04

On-Brand Devices [MAGNIFUSE® II Bone Graft]

• 00643169216242: DBM 7509510 MAGNIFUSE II 2.5 CM X 10 CM
• 00643169216235: DBM 7509505 MAGNIFUSE II 2.5 CM X 5 CM