GUDID 00763000650827

SET 9736464 BASIC INST AUTOGUIDE II EN

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system

• Primary Device ID: 00763000650827
• NIH Device Record Key: 9329e126-2264-4fb9-bde0-f1262c58dc71
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 9736464
• Company DUNS: 835233107
• Company Name: MEDTRONIC NAVIGATION, 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: false
• 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: true
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000650827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191597

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-04
• Device Publish Date: 2023-08-26

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

• 00763000927127 - Medtronic: 2024-12-13 INST SET 9735283 SOLERA 5.5/6.0 DRVR
• 00763000927189 - Medtronic: 2024-12-13 INST SET 9734495 REFERENCING STD
• 00763000927233 - Medtronic: 2024-12-13 INST SET 9734494 TACTILE PROBES
• 00763000922412 - Medtronic: 2024-11-25 INST SET 9733935 CRANIAL PASSIVE
• 00763000927035 - NavLock™: 2024-11-25 INST SET 9734833 UNIVERSAL NAVLOCK
• 00763000927042 - NavLock™: 2024-11-25 INST SET 9734834 CAPSTONE TRIALS
• 00763000927059 - NavLock™: 2024-11-25 INST SET 9734835 CLYDESDALE TRIALS
• 00763000927066 - Medtronic: 2024-11-25 INST SET 9734836 TLIF/DLIF INSERTER