Catalog Number

566583

Brand Name

METRON

Version/Model Number

566583

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090198,K090198,K090198

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

41477125-0e45-4398-b0c4-520e956be0ba

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

20885914070752

Quantity per Package

20

Contains DI Package

10885914070755

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-