Catalog Number

Z-401CE

Brand Name

Elefix

Version/Model Number

Z-401CE

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

76af2ece-75f6-4ea3-856c-c18544e04b50

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

May 26, 2017

Package DI Number

14931921818401

Quantity per Package

3

Contains DI Package

04931921818404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box