MASTERGRAFT®Putty

GUDID 00885074478715

PUTTY 7600701 MTRGFT PUTY 0.75 CC KT

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, animal-derived, bioabsorbable

• Primary Device ID: 00885074478715
• NIH Device Record Key: 00c5c0fd-e089-4d89-9111-196944b9d807
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MASTERGRAFT®Putty
• Version Model Number: 7600701
• 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	00885074478715 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140374

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®Putty]

• 00643169486454: BIOLOGICS 7600709 MSTRGRFT PUTY 9 CC KIT
• 00643169486447: BIOLOGICS 7600706 MSTRGRFT PUTY 6 CC KIT
• 00643169486430: BIOLOGICS 7600703 MSTRGRFT PUTY 3 CC KIT
• 00643169486423: BIOLOGICS 7600702 MSTRGFT PUTY 1.5 CC KT
• 00643169486416: BIOLOGICS 7600701 MTRGFT PUTY 0.75 CC KT
• 00885074478791: PUTTY 7600709 MSTRGRFT PUTY 9 CC KIT
• 00885074478784: PUTTY 7600706 MSTRGRFT PUTY 6 CC KIT
• 00885074478760: PUTTY 7600703 MSTRGRFT PUTY 3 CC KIT
• 00885074478753: PUTTY 7600702 MSTRGFT PUTY 1.5 CC KT
• 00885074478715: PUTTY 7600701 MTRGFT PUTY 0.75 CC KT