Catalog Number

989803192541

Brand Name

Soft Cloth Solid Gel Small ECG Electrode

Version/Model Number

989803192541

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

K023503

Product Code

DRX

Product Code Name

Electrode, electrocardiograph

Public Device Record Key

812a5d3f-6058-4942-af92-e1dc8b500c3d

Public Version Date

November 24, 2021

Public Version Number

4

DI Record Publish Date

September 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-