Catalog Number

-

Brand Name

OmniVersa High Conductivity Electrodes

Version/Model Number

26135

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

af3d1be5-3083-4e98-9745-1e173b46ad48

Public Version Date

August 29, 2022

Public Version Number

2

DI Record Publish Date

July 22, 2022

Package DI Number

10858703006303

Quantity per Package

4

Contains DI Package

00858703006306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack