Stimulation coil DuoMAG 60BF-NL 47-655

GUDID 08592566476556

47-655

DEYMED Diagnostic s.r.o.

Magnetic neural stimulation system

• Primary Device ID: 08592566476556
• NIH Device Record Key: 5e9473be-cb3d-471f-8d56-173dbcee9877
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stimulation coil DuoMAG 60BF-NL
• Version Model Number: 47-655
• Catalog Number: 47-655
• Company DUNS: 495566056
• Company Name: DEYMED Diagnostic s.r.o.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com
• Phone: +1 858 229 9218
• Email: hello@neuralacemedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 107 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08592566476556 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210021

FDA Product Code

• QPL: Electromagnetic Stimulator, Pain Relief

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: 2023-11-03
• Device Publish Date: 2023-10-26

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