O-Arm

GUDID 00613994462428

CONTROLLER 9733292R WIRELESS O-ARM RWK

MEDTRONIC NAVIGATION, INC.

Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00613994462428
• NIH Device Record Key: 0c2bdeb6-2e5c-4012-b624-2ad27af3787f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-Arm
• Version Model Number: 9733292R
• 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
• 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	00613994462428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050996

FDA Product Code

• OXO: Image-intensified fluoroscopic x-ray system, mobile

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: 2025-12-05
• Device Publish Date: 2025-11-27

On-Brand Devices [O-Arm]

• 00763000616564: O-ARM SYS BI70002000 O2 UE 120V B EN UEN
• 00643169618121: O-ARM SYS BI70002000 O2 UE 240V F DE DE
• 00613994462428: CONTROLLER 9733292R WIRELESS O-ARM RWK