Catalog Number

-

Brand Name

Ives EEG Solutions

Version/Model Number

DCPE-25/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

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

08bb8973-868a-4061-a92f-0d68cf1e4e93

Public Version Date

April 07, 2020

Public Version Number

2

DI Record Publish Date

October 29, 2019

Package DI Number

00850012681168

Quantity per Package

10

Contains DI Package

00850012681069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box