HORIZON® E-z Cool Coil with Navigation

GUDID 05060229532541

THE MAGSTIM COMPANY LIMITED

Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary Magnetic neural stimulation system, stationary

• Primary Device ID: 05060229532541
• NIH Device Record Key: b2a8418b-a179-49d9-b713-fae46475033f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HORIZON® E-z Cool Coil with Navigation
• Version Model Number: 5367-00
• 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: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com
• Phone: +441994240798
• Email: QA.RA@magstim.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060229532541 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183376

FDA Product Code

• OBP: Transcranial Magnetic Stimulator

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2019-08-29

Devices Manufactured by THE MAGSTIM COMPANY LIMITED

• 05060229532107 - D70 Alpha Sham Coil: 2024-03-19 D70 Alpha Sham Coil
• 05060229532923 - StimGuide Pro Pointer Tool: 2024-01-09 StimGuide Pro Pointer Tool
• 05060229532930 - StimGuide Pro Head Reference: 2024-01-09 StimGuide Pro Head Reference
• 05060229532947 - StimGuide Pro MT Coil Tracker Tool: 2024-01-09 StimGuide Pro MT Coil Tracker Tool
• 05060229532954 - StimGuide Pro E-z Coil Tracker Tool: 2024-01-09 StimGuide Pro E-z Coil Tracker Tool
• 05060229533050 - TMS-EEG Cable: 2024-01-09 TMS-EEG Cable
• 05060229532978 - Horizon Current Adaptor - Standard: 2023-10-03 Sham adaptor for HorizonSystems.
• 05060229532985 - Horizon Current Adaptor - Placebo: 2023-10-03 Placebo adaptor for HorizonSystems.