MASTERGRAFT® Contain

GUDID 00643169585461

STRIP 7800510 MASTERGRAFT CONTAIN 10CM

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, synthetic

• Primary Device ID: 00643169585461
• NIH Device Record Key: f6fa0b33-0a89-4361-8d74-879cc2493ef5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTERGRAFT® Contain
• Version Model Number: 7800510
• 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: 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

• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169585461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151172

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: 2015-08-27

On-Brand Devices [MASTERGRAFT® Contain]

• 00643169585478: STRIP 7800520 MASTERGRAFT CONTAIN 20CM
• 00643169585461: STRIP 7800510 MASTERGRAFT CONTAIN 10CM
• 00643169585454: STRIP 7800555 MASTERGRAFT CONTAIN 5CM X2
• 00643169585447: STRIP 7800505 MASTERGRAFT CONTAIN 5CM