USB to Electrical Stimulation Box Cable

GUDID 00817020020310

INTELLIGENT HEARING SYSTEMS CORP.

Somatosensory electrical stimulation system Somatosensory electrical stimulation system Somatosensory electrical stimulation system
Primary Device ID00817020020310
NIH Device Record Key3de110a2-5514-4dd6-8b49-68d7715a574f
Commercial Distribution StatusIn Commercial Distribution
Brand NameUSB to Electrical Stimulation Box Cable
Version Model NumberM014911
Company DUNS154870455
Company NameINTELLIGENT HEARING SYSTEMS CORP.
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 Datetrue
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
GS100817020020310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWFStimulator, Electrical, Evoked Response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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