NeMus 2

GUDID 08056446900376

EEG/EMG/EP Amplifier

EB NEURO SPA

Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system Evoked-potential graphic recording system

• Primary Device ID: 08056446900376
• NIH Device Record Key: fc1701b4-73cd-4df1-a7d9-8eb812a8571f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeMus 2
• Version Model Number: B9700066010
• Company DUNS: 339182263
• Company Name: EB NEURO SPA
• 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: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com
• Phone: +390554565111
• Email: info@ebneuro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08056446900376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133517

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2019-04-18
• Device Publish Date: 2019-04-10

On-Brand Devices [NeMus 2]

• 08056446900376: EEG/EMG/EP Amplifier
• 08056446900369: EEG/EMG/EP Amplifier with accessories