MASTERGRAFT® Mini Granules

GUDID 00613994512758

MINIGRANULES 8600105INT MASTERGRAFT 5CC

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, synthetic

• Primary Device ID: 00613994512758
• NIH Device Record Key: 50f8e8af-3819-4ee1-a015-b31e0a48433e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTERGRAFT® Mini Granules
• Version Model Number: 8600105INT
• 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	00613994512758 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082917

FDA Product Code

• LYC: Bone grafting material, synthetic

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: 2018-12-19
• Device Publish Date: 2018-11-18

On-Brand Devices [MASTERGRAFT® Mini Granules]

• 00613994512826: MINIGRANULES 8600100 MASTERGRAFT 0.5CC
• 00613994512819: MINIGRANULES 8600100INT MASTERGRAFT .5CC
• 00613994512802: MINIGRANULES 8600101 MASTERGRAFT 1CC
• 00613994512796: MINIGRANULES 8600101INT MASTERGRAFT 1CC
• 00613994512789: MINIGRANULES 8600103 MASTERGRAFT 3CC
• 00613994512772: MINIGRANULES 8600103INT MASTERGRAFT 3CC
• 00613994512765: MINIGRANULES 8600105 MASTERGRAFT 5CC
• 00613994512758: MINIGRANULES 8600105INT MASTERGRAFT 5CC