Catalog Number

-

Brand Name

Physiotrode

Version/Model Number

PT3X5

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130987

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

0bd25746-1f67-4cef-93df-7e5f5c065e21

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

June 03, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-