GRAFTON PLUS® DBM

GUDID 00643169134386

DBM T45005INT 5CC PASTE GRAFTON PLUS

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived Bone matrix implant, human-derived

• Primary Device ID: 00643169134386
• NIH Device Record Key: 87e1d4f4-d523-423b-806b-bb58f78f3636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAFTON PLUS® DBM
• Version Model Number: T45005INT
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169134386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043048

FDA Product Code

• MBP: Filler, bone void, osteoinduction (w/o human growth factor)

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: 2016-04-03

On-Brand Devices [GRAFTON PLUS® DBM]

• 00643169134393: DBM T45010INT 10CC PASTE GRAFTON PLUS
• 00643169134386: DBM T45005INT 5CC PASTE GRAFTON PLUS
• 00643169134379: DBM T45001INT 1CC PASTE GRAFTON PLUS
• 00643169965096: DBM T45001INT 1CC PASTE GRAFTON PLUS