Unibody™

GUDID 20613994747840

FIDUCIALS FM-4013 IMAGE 13mm GLOBAL AIMD

MEDTRONIC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 20613994747840
• NIH Device Record Key: 835e5ed4-dd4a-4024-b664-fc74fffdbe6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unibody™
• Version Model Number: FM-4013
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• Device Count: 6
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994747846 [Unit of Use]
GS1	20613994747840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033619

FDA Product Code

• HAW: Neurological stereotaxic Instrument

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: 2015-11-17

On-Brand Devices [Unibody™]

• 20613994747840: FIDUCIALS FM-4013 IMAGE 13mm GLOBAL AIMD
• 20613994747833: FIDUCIAL FM-4010 IMAGE 10MM GLOBAL AIMD
• 20613994747826: FIDUCIALS FM-4007 IMAGE 7mm GLOBAL AIMD