MASTERGRAFT® Granules

GUDID 00721902168741

BIOLOGIC 7600110 85 BTCP 15 HA 10CC VIAL

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, synthetic

• Primary Device ID: 00721902168741
• NIH Device Record Key: 79f1f8ca-7e94-4886-86db-3ccb85d2f337
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTERGRAFT® Granules
• Version Model Number: 7600110
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902168741 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012506

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: 2015-07-20

On-Brand Devices [MASTERGRAFT® Granules]

• 00721902184994: BIOLOGIC 7600130 85 BTCP 15 HA 30CC VIAL
• 00721902184987: BIOLOGIC 7600115 85 BTCP 15 HA 15CC VIAL
• 00721902168741: BIOLOGIC 7600110 85 BTCP 15 HA 10CC VIAL
• 00721902168734: BIOLOGIC 7600105 85 BTCP 15 HA 5CC VIAL