GRAFTON® DBM

GUDID 00643169965065

DBM T44135INT 15CC GRAFTON ORTHOBLEND LG

MEDTRONIC SOFAMOR DANEK, INC.

Bone matrix implant, human-derived

• Primary Device ID: 00643169965065
• NIH Device Record Key: d16b71ea-916b-48d2-91e8-1acaeb4b8367
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRAFTON® DBM
• Version Model Number: T44135INT
• 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	00643169965065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051195

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: 2018-01-26

On-Brand Devices [GRAFTON® DBM]

• 00643169134577: DBM T43105INT 5CC GRAFTON PUTTY
• 00643169134560: DBM T43103INT 2.5CC GRAFTON PUTTY
• 00643169134553: DBM T43102INT 1CC GRAFTON PUTTY
• 00643169134546: DBM T43101INT 0.5CC GRAFTON PUTTY
• 00643169134539: DBM T42308INT GRAFTON M PLUGS 8MMX10MM
• 00643169134508: DBM T42150INT 5CM X 5CM FLEX GRAFTON
• 00643169134492: DBM T42110INT 2.5CMX5CM FLEXGRAFTON
• 00643169134485: DBM T42100INT 2.5CMX10CM FLEX GRAFTON
• 00643169134478: DBM T42090INT 1.5CMX1.5CM FLEX GRAFTON
• 00643169134324: DBM T44115INT 15CC GRAFTON CRUNCH
• 00643169134300: DBM T43205INT 0.5CC GRAFTON PUTTY SYRNG
• 00643169134294: DBM T43204INT 0.25CC GRAFTON PUTTY SYRNG
• 00643169134287: DBM T43110INT 10CC GRAFTON PUTTY
• 00643169965065: DBM T44135INT 15CC GRAFTON ORTHOBLEND LG
• 00643169965010: DBM T43204INT 0.25CC GRAFTON PUTTY SYRNG
• 00643169965003: DBM T43110INT 10CC GRAFTON PUTTY
• 00643169964990: DBM T43105INT 5CC GRAFTON PUTTY
• 00643169964983: DBM T43103INT 2.5CC GRAFTON PUTTY
• 00643169964976: DBM T43102INT 1CC GRAFTON PUTTY
• 00643169964969: DBM T43101INT 0.5CC GRAFTON PUTTY
• 00643169964952: DBM T42308INT GRAFTON M PLUGS 8MMX10MM
• 00643169965089: DBM T44150INT 10CC GRAFTON ORTHOBLEND SM