Ives EEG Solutions DCPEX-21B

GUDID 00850012681182

Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, black cup, with disposable 21 lead harness

IVES EEG SOLUTIONS, LLC

Analytical scalp electrode, single-use
Primary Device ID00850012681182
NIH Device Record Key12854827-c1f5-4245-8f29-d21727f0e88a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIves EEG Solutions
Version Model NumberDCPEX-21/B
Catalog NumberDCPEX-21B
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 Batchfalse
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
GS100850012681182 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-05-08
Device Publish Date2020-11-06

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00850012681250Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, soft cup, with disposab
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00850012681182Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 21 leads, black cup, with disposa
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