HORIZON® E-z Cool Coil with Navigation

GUDID 05060229532541

THE MAGSTIM COMPANY LIMITED

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

• 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
• 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