Catalog Number

-

Brand Name

Zynex Medical Electrodes

Version/Model Number

300117

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K000947

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

295d1b67-db26-40dd-a1e2-0e5cdeba808d

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

October 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-