FUSION Compact ™

GUDID 00643169647121

STAND 9735550 EMITTER FUSION COMPACT

MEDTRONIC NAVIGATION, INC.

ENT stereotactic surgery system ENT stereotactic surgery system

• Primary Device ID: 00643169647121
• NIH Device Record Key: 59225407-fb97-448c-8a5a-429b14686dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FUSION Compact ™
• Version Model Number: 9735550
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00643169647121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153247

FDA Product Code

• PGW: Ear, Nose, and Throat Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-10

On-Brand Devices [FUSION Compact ™]

• 00643169672956: COMPUTER 9735602 FUSION COMP LOADED
• 00643169647121: STAND 9735550 EMITTER FUSION COMPACT
• 00763000099787: COMPUTER 9735602R FUSION COMP RFB LOADED