MAGNIFUSE® Bone Graft

GUDID 00613994986542

DBM 7509145 MAGNIFUSE 1.75 X 5 CM

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00613994986542
• NIH Device Record Key: f1af72e8-7f22-483a-a76a-b996a6a3c7d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAGNIFUSE® Bone Graft
• Version Model Number: 7509145
• 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	00613994986542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082615

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: 2015-12-01

On-Brand Devices [MAGNIFUSE® Bone Graft]

• 00643169141858: BONE GRAFT 7509141INT MG 1.75 CM X 10 CM
• 00643169104013: DBM 7509111 MAG SINGLE 1 X 10CM
• 00643169104006: DBM 7509041 MAG SINGLE 1.75 X 10CM
• 00643169103993: DBM 7509045 MAG SINGLE 1.75 X 5CM
• 00643169103986: DBM 7509115 MAG SINGLE 1 X 5CM
• 00613994986559: DBM 7509215 MAGNIFUSE 1 X 5CM
• 00613994986542: DBM 7509145 MAGNIFUSE 1.75 X 5 CM
• 00613994986535: DBM 7509141 MAGNIFUSE 1.75 X 10CM
• 00613994986528: DBM 7509225 MAGNIFUSE 2.5 X 5CM
• 00613994986511: DBM 7509221 MAGNIFUSE 2.5 X 10CM
• 00613994986504: DBM 7509211 MAGNIFUSE 1 X 10CM
• 00613994986498: DBM 7509212 MAGNIFUSE 1 X 20CM
• 00613994986481: DBM 7509007 MAGNIFUSE 7.5 X 25mm
• 00613994986474: DBM 7509010 MAGNIFUSE 10 X 25mm
• 00613994986467: DBM 7509014 MAGNIFUSE 14 X 25mm