Table MagCart NL 41-056

GUDID 08592566410567

41-056

DEYMED Diagnostic s.r.o.

Magnetic neural stimulation system

• Primary Device ID: 08592566410567
• NIH Device Record Key: 126c8e88-9bbe-4fc8-9491-88856ac74504
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Table MagCart NL
• Version Model Number: 41-056
• Catalog Number: 41-056
• 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	08592566410567 [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

Devices Manufactured by DEYMED Diagnostic s.r.o.

• 08592566001208 - Disposable blunted needles: 2023-11-03 00-120
• 08592566410567 - Table MagCart NL: 2023-11-0341-056
• 08592566410567 - Table MagCart NL: 2023-11-03 41-056
• 08592566419003 - TruScan Neurofeedback Adapter: 2023-11-03
• 08592566431395 - TruScan LT 24 Neurofeedback headbox: 2023-11-03 Neurofeedback headbox
• 08592566432392 - TruScan LT 32 Neurofeedback headbox: 2023-11-03 43-239
• 08592566449000 - TruScan Neurofeedback optical cable V3.3L: 2023-11-03 44-900
• 08592566453618 - Deymed Li-ion Battery: 2023-11-03 Neurofeedback device accessories
• 08592566471506 - Magnetic stimulator DuoMAG XT-NL: 2023-11-03 47-150