O-armTM O2 Imaging System

GUDID 00763000709631

O-ARM SYS BI70002000 O2 UE 120V B EN UEN

MEDTRONIC NAVIGATION, INC.

Portable general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 00763000709631
• NIH Device Record Key: fb856b10-fde8-4905-a443-b327f40d65b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O-armTM O2 Imaging System
• Version Model Number: BI70002000
• Company DUNS: 803580559
• 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: false
• Serial Number: true
• 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
• 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 Dimensions

• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram
• Weight: 1087 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000709631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240465

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: 2024-09-03
• Device Publish Date: 2024-08-26

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

• 00643169618121 - O-arm: 2024-10-18 O-ARM SYS BI70002000 O2 UE 240V F DE DE
• 00763000927141 - Medtronic: 2024-10-14 REF SET 9735501 SPINE REF REVISION
• 00763000705008 - Stealth Autoguide: 2024-10-01 SYSTEM 29631 STEALTH AUTOGUIDE ENG ONLY
• 00763000709631 - O-armTM O2 Imaging System: 2024-09-03O-ARM SYS BI70002000 O2 UE 120V B EN UEN
• 00763000709631 - O-armTM O2 Imaging System: 2024-09-03 O-ARM SYS BI70002000 O2 UE 120V B EN UEN
• 00763000521370 - VISUALASE: 2024-08-12 SYSTEM 9735542 15W VISUALASE
• 00763000457365 - Medtronic Navigation: 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-E
• 00763000457389 - Medtronic Navigation: 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SC
• 00763000457402 - Medtronic Navigation: 2024-06-17 SFW KIT 9735917 S8 DBS 2ND LIC EU-SE