Catalog Number

ZV-181E

Brand Name

Elefix V Paste for EEG & EMG

Version/Model Number

ZV-181E

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

-

Product Code

GYB

Product Code Name

MEDIA, ELECTROCONDUCTIVE

Public Device Record Key

b3476c4c-e666-4d72-8e55-d69b066872d9

Public Version Date

April 01, 2020

Public Version Number

1

DI Record Publish Date

March 24, 2020

Package DI Number

04931921005781

Quantity per Package

2

Contains DI Package

04931921005842

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box