INFUSE® Bone Graft

GUDID 00613994239525

BONE GRAFT KIT 7510100 INFUSE X SMALL

MEDTRONIC SOFAMOR DANEK, INC.

Spinal fusion graft kit Spinal fusion graft kit

• Primary Device ID: 00613994239525
• NIH Device Record Key: af596042-03b1-4197-a1aa-18b36871232f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFUSE® Bone Graft
• Version Model Number: 7510100
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994239525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000058

FDA Product Code

• NPZ: Bone grafting material, dental, with biologic component

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-28
• Device Publish Date: 2014-09-23

On-Brand Devices [INFUSE® Bone Graft]

• 00613994239525: BONE GRAFT KIT 7510100 INFUSE X SMALL
• 00613994239518: BONE GRAFT KIT 7510050 INFUSE XX SMALL
• 00681490843829: BONE GRAFT KIT 7510800 INFUSE LARGE II
• 00681490843812: BONE GRAFT KIT 7510600 INFUSE LARGE
• 00681490843805: BONE GRAFT KIT 7510400 INFUSE MEDIUM
• 00681490843782: BONE GRAFT KIT 7510200 INFUSE SMALL