Geodesic EEG System - GES 400 Series

GUDID 00850033571004

Magstim, Inc.

Electroencephalograph

• Primary Device ID: 00850033571004
• NIH Device Record Key: 470081df-0f09-43f9-8213-e7d597fcafcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geodesic EEG System - GES 400 Series
• Version Model Number: 140xxxx
• Company DUNS: 061639577
• Company Name: Magstim, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033571004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131882

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

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: 2022-02-02
• Device Publish Date: 2022-01-25

Devices Manufactured by Magstim, Inc.

• 00850033571004 - Geodesic EEG System - GES 400 Series: 2022-02-02
• 00850033571004 - Geodesic EEG System - GES 400 Series: 2022-02-02
• 00850033571011 - MicroCel Geodesic Sensor Net - MCGSN 100 Series: 2022-02-02
• 00850033571028 - GeoSource 2.0 Source Estimation Software: 2022-02-02
• 00850033571035 - HydroCel Geodesic Sensor Net - HCGSN 130: 2022-02-02