Magnetic stimulator DuoMAG XT-NL 47-150

GUDID 08592566471506

47-150

DEYMED Diagnostic s.r.o.

Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system Magnetic neural stimulation system

• Primary Device ID: 08592566471506
• NIH Device Record Key: 4e511969-c5fe-4c67-88ed-3bc29b0caa84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Magnetic stimulator DuoMAG XT-NL
• Version Model Number: 47-150
• Catalog Number: 47-150
• 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	08592566471506 [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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