Horizon 3.0 PSU (Power Supply Unit)

GUDID 05060229532701

THE MAGSTIM COMPANY LIMITED

Magnetic neural stimulation system

• Primary Device ID: 05060229532701
• NIH Device Record Key: b5eda597-3ad9-4b59-8e2c-6b7894a82443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Horizon 3.0 PSU (Power Supply Unit)
• Version Model Number: 5801-00
• Company DUNS: 500375274
• Company Name: THE MAGSTIM COMPANY LIMITED
• 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: 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

Customer Support Contacts

• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com
• Phone: +441994240798
• Email: regulatory@magstim.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060229532701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211389

FDA Product Code

• OBP: Transcranial Magnetic Stimulator

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: 2021-12-29
• Device Publish Date: 2021-12-21

Devices Manufactured by THE MAGSTIM COMPANY LIMITED

• 05060229530868 - Magstim Double 70mm Air Film Coil: 2025-02-27 Double 70mm Placebo Air Film Coil
• 05060229532411 - D25 Alpha B.I. Coil: 2025-02-27
• 05060229533012 - Horizon 3.0 Coil Holder: 2025-02-27
• 05060229533029 - Horizon 3.0 Camera Stand: 2025-02-27
• 05060229533074 - Horizon 3.0 MEP Pod: 2024-11-07
• 05060229533081 - Horizon 3.0 Inspire Mainframe: 2024-11-07
• 05060229533005 - Horizon 3.0 Interface Unit: 2024-05-17 Horizon 3.0 Interface Unit
• 05060229533036 - Horizon 3.0 ez Cool Coil: 2024-05-17 Horizon 3.0 ez Cool Coil