Catalog Number

Z-181JE

Brand Name

Elefix

Version/Model Number

Z-181JE

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

ee76c76e-6de0-4f1c-af43-742022da58cc

Public Version Date

October 22, 2018

Public Version Number

3

DI Record Publish Date

September 05, 2016

Package DI Number

14931921805746

Quantity per Package

10

Contains DI Package

04931921805749

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box