Ives EEG Solutions DCPEX-25/S

GUDID 00850012681243

Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 25 leads, soft cup, with disposable 25 lead harness

IVES EEG SOLUTIONS, LLC

Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use Analytical scalp electrode, single-use
Primary Device ID00850012681243
NIH Device Record Keybf254112-b6f5-4543-a9e3-88e14e80aec7
Commercial Distribution StatusIn Commercial Distribution
Brand NameIves EEG Solutions
Version Model NumberDCPEX-25/S
Catalog NumberDCPEX-25/S
Company DUNS015020106
Company NameIVES EEG SOLUTIONS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012681243 [Primary]

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 Date2020-12-18
Device Publish Date2020-12-10

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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