Geodesic EEG System

GUDID 00863003000305

Electroencephalograph

ELECTRICAL GEODESICS, INC.

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph

Primary Device ID	00863003000305
NIH Device Record Key	c9c1d66f-303d-40df-ac86-38c18379c1f4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Geodesic EEG System
Version Model Number	GES 400 Series
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

Device Dimensions

Length	102 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter
Width	150 Centimeter
Length	102 Centimeter

Operating and Storage Conditions

Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863003000305 [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	2016-10-03

Devices Manufactured by ELECTRICAL GEODESICS, INC.

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00863003000312 - Geodesic Photogrammetry System	2018-03-29 Full-montage Standard Electroencephalograph CAMERA, SURGICAL AND ACCESSORIES
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.