HydroCel Geodesic Sensor Net - HCGSN 130

GUDID 00850033571035

Magstim, 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
Primary Device ID00850033571035
NIH Device Record Key78e093e7-0040-49c8-9022-550659082db1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHydroCel Geodesic Sensor Net - HCGSN 130
Version Model Number473xxxx
Company DUNS061639577
Company NameMagstim, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850033571035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-02
Device Publish Date2022-01-25

Devices Manufactured by Magstim, Inc.

00850033571004 - Geodesic EEG System - GES 400 Series2022-02-02
00850033571011 - MicroCel Geodesic Sensor Net - MCGSN 100 Series2022-02-02
00850033571028 - GeoSource 2.0 Source Estimation Software2022-02-02
00850033571035 - HydroCel Geodesic Sensor Net - HCGSN 1302022-02-02
00850033571035 - HydroCel Geodesic Sensor Net - HCGSN 1302022-02-02

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