HydroCel Geodesic Sensor Net

GUDID 00863003000329

EEG Electrode Array

ELECTRICAL GEODESICS, INC.

Electroencephalograph

• Primary Device ID: 00863003000329
• NIH Device Record Key: d7eac1d6-3c49-4a55-b95b-0d64886e8c91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroCel Geodesic Sensor Net
• Version Model Number: HCGSN 130
• Company DUNS: 809845365
• Company Name: ELECTRICAL GEODESICS, INC.
• 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: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com
• Phone: 541-687-7962
• Email: supportteam@egi.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863003000329 [Primary]

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-04

Devices Manufactured by ELECTRICAL GEODESICS, INC.

• 00863003000305 - Geodesic EEG System: 2018-03-29 Electroencephalograph
• 00863003000312 - Geodesic Photogrammetry System: 2018-03-29 Full-montage Standard Electroencephalograph CAMERA, SURGICAL AND ACCESSORIES
• 00863003000329 - HydroCel Geodesic Sensor Net: 2018-03-29EEG Electrode Array
• 00863003000329 - HydroCel Geodesic Sensor Net: 2018-03-29 EEG Electrode Array
• 00863003000336 - MicroCel Geodesic Sensor Net: 2018-03-29 EEG Electrode Array
• 00863003000343 - GeoSource: 2018-03-29 Source Localization Software For Electroencephalograph Or Magnetoencephalograph Electroencephalograph.