Catalog Number

36-3000-38

Brand Name

Pharmaceutical Innovations

Version/Model Number

Lectron II Electrode Conductivity Gel

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

Yes

Prescription Use (Rx)

-

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

faad995c-08f0-4d5a-a70a-ad2e356d7370

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

Package DI Number

10300363000387

Quantity per Package

1

Contains DI Package

00300363000380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-