Axilum Robotics 2-01-02

GUDID 03701354600058

Axilum Robotics TMS-Cobot TS MV

AXILUM ROBOTICS

Magnetic neural stimulation system, mobile

• Primary Device ID: 03701354600058
• NIH Device Record Key: ace1d6b9-0bc9-48ca-acf2-90a9129d6562
• Commercial Distribution Discontinuation: 2021-10-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Axilum Robotics
• Version Model Number: TMS-Cobot-2
• Catalog Number: 2-01-02
• Company DUNS: 263039073
• Company Name: AXILUM ROBOTICS
• 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: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701354600058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182768

FDA Product Code

• QFF: Electromechanical Arm For A Transcranial Magnetic Stimulation System

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: 2021-10-29
• Device Publish Date: 2021-10-21

On-Brand Devices [Axilum Robotics]

• 03701354630116: Axilum Robotics TMS-Explorer Tracking System for TMS-Cobot TS MV
• 03701354620261: Polaris compatible TMS coil adaptation kit for MagVenture Cool-B65-CO coil, for TMS-Cobot TS MV
• 03701354620117: Axilum Robotics TMS-Cobot TS MV
• 03701354620285: TMS coil adaptation kit for MagVenture Cool-B65-A/P-CO coil, for TMS-Cobot TS MV
• 03701354600058: Axilum Robotics TMS-Cobot TS MV
• 03701354600034: Coil adaptation kit for MagVenture Cool-B65-CO coil, for TMS-Cobot TS MV