Catalog Number

-

Brand Name

Disposable Adhesive Surface Electrodes

Version/Model Number

DENIS10026

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

K120494,K120494

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

75c5e034-f03a-4f3c-aaa7-626d5ea0867f

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

June 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-