waveguard

GUDID B195XC161

eeg cap accessories

eemagine Medical Imaging Solutions GmbH

Electroencephalographic electrode cap, single-use

• Primary Device ID: B195XC161
• NIH Device Record Key: 39617396-b698-4f7c-8100-62c45535ed51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: waveguard
• Version Model Number: XC-161
• Company DUNS: 313152485
• Company Name: eemagine Medical Imaging Solutions 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: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com
• Phone: +493029048404
• Email: support@eemagine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B195XC161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110223

FDA Product Code

• GXY: ELECTRODE, CUTANEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-17

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