NEXDRIVE™

GUDID 00643169986770

DRIVE MI-2000 NEXDRIVE MICROPOSITION

MEDTRONIC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00643169986770
• NIH Device Record Key: 47d67e79-606e-42a0-bf72-c61d1dda225e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEXDRIVE™
• Version Model Number: MI-2000
• Company DUNS: 796986144
• Company Name: MEDTRONIC, 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169986770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022100

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-29
• Device Publish Date: 2018-10-29

On-Brand Devices [NEXDRIVE™]

• 00613994747860: ACCY MI-2000 NEXDRIVE MANUAL GLOBAL AIMD
• 00613994747853: ACCY MI-1000 NEXDRIVE MAN W/ DIG AIMD
• 00643169986770: DRIVE MI-2000 NEXDRIVE MICROPOSITION
• 00643169986763: DRIVE MI-1000 NEXDRIVE MICROPOSITION