Ives EEG Solutions

GUDID 00850012681090

Ives MR Conditional Electrode System Harness, 23 lead wire harness, MR Unsafe (disconnect from electrode set before CT or MR imaging)

IVES EEG SOLUTIONS, LLC

Analytical scalp lead
Primary Device ID00850012681090
NIH Device Record Key0bd36788-d0d8-4eb1-8d79-18469bfd4d42
Commercial Distribution StatusIn Commercial Distribution
Brand NameIves EEG Solutions
Version Model NumberHAR-23
Company DUNS015020106
Company NameIVES EEG SOLUTIONS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012681090 [Primary]

FDA Product Code

IKDCable, Electrode

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-13
Device Publish Date2019-11-05

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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