Ives EEG Solutions

GUDID 00850012681045

MR Conditional Disposable EEG Soft Cup electrode system, 21 lead, soft cups, CT compatible

IVES EEG SOLUTIONS, LLC

Analytical scalp electrode, single-use
Primary Device ID00850012681045
NIH Device Record Key984c6994-f260-404d-af85-510ee3f7a8dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameIves EEG Solutions
Version Model NumberDCPE-21/S
Company DUNS015020106
Company NameIVES EEG SOLUTIONS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone978-358-8006
Emailinfo@iveseegsolutions.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012681045 [Primary]
GS100850012681137 [Package]
Package: Box [10 Units]
Discontinued: 2020-04-06
Not in Commercial Distribution
GS110850012681042 [Package]
Package: Box [10 Units]
Discontinued: 2020-04-06
Not in Commercial Distribution
GS120850012681049 [Package]
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-06
Device Publish Date2019-10-29

On-Brand Devices [Ives EEG Solutions]

00850012681076MR Conditional Disposable EEG Soft Cup Electrode System, 27 lead, soft cup, CT compatible
00850012681069MR Conditional Disposable EEG Soft Cup Electrode System, 25 lead, soft cups, CT compatible
00850012681052MR Conditional Disposable EEG Soft Cup electrode system, 23 lead, soft cups, CT compatible
00850012681045MR Conditional Disposable EEG Soft Cup electrode system, 21 lead, soft cups, CT compatible
00850012681038MR Conditional Disposable EEG Cup Electrode System, 27 lead, black cup, CT compatible
00850012681021MR Conditional Disposable EEG Cup Electrode System, 25 lead, black cup, CT compatible
00850012681014MR Conditional Disposable EEG Cup electrode system, 23 lead, black cup, CT compatible
00850012681007MR Conditional Disposable EEG Cup Electrode System, 21 lead, black cup, CT compatible
00850012681113Ives MR Conditional Electrode System Harness, 27 lead wire harness, MR Unsafe (disconnect from e
00850012681106Ives MR Conditional Electrode System Harness, 25 lead wire harness, MR Unsafe (disconnect from e
00850012681090Ives MR Conditional Electrode System Harness, 23 lead wire harness, MR Unsafe (disconnect from e
00850012681083Ives MR Conditional Electrode System Harness, 21 lead wire harness, MR Unsafe (disconnect from e
00850012681250Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, soft cup, with disposab
00850012681243Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 25 leads, soft cup, with disposab
00850012681236Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 23 leads, soft cup, with disposab
00850012681229Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, soft cup, with disposab
00850012681182Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, black cup, with disposa
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