Catalog Number

-

Brand Name

Ives EEG Solutions

Version/Model Number

DCPE-21/S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071118,K071118,K071118,K071118

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

984c6994-f260-404d-af85-510ee3f7a8dd

Public Version Date

April 07, 2020

Public Version Number

2

DI Record Publish Date

October 29, 2019

Package DI Number

00850012681137

Quantity per Package

10

Contains DI Package

00850012681045

Package Discontinue Date

April 06, 2020

Package Status

Not in Commercial Distribution

Package Type

Box