g.USBamp 0216

GUDID EBCI02160

The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG.

g.tec medical engineering GmbH

Multiple physiological signal amplifier

• Primary Device ID: EBCI02160
• NIH Device Record Key: 8a212b19-e965-47bf-9ae2-c58481dca095
• Commercial Distribution Discontinuation: 2019-04-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: g.USBamp
• Version Model Number: USB Biosignal Amplifier
• Catalog Number: 0216
• Company DUNS: 300916041
• Company Name: g.tec medical engineering GmbH
• 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: false
• 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: +437251222400
• Email: support@gtec.at

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBCI02160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060803

FDA Product Code

• GWL: Amplifier, Physiological Signal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-21
• Device Publish Date: 2017-04-12

On-Brand Devices [g.USBamp]

• EBCI0216US0: The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain
• EBCI02160: The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain