Catalog Number

-

Brand Name

Cathay

Version/Model Number

CM5050FC

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)

-

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

ee99e768-3d7f-467a-9519-1a5fbeb3a4ee

Public Version Date

December 03, 2021

Public Version Number

1

DI Record Publish Date

November 25, 2021

Package DI Number

16959006303589

Quantity per Package

180

Contains DI Package

06959006303582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box