Catalog Number

-

Brand Name

Technomed Europe

Version/Model Number

TE/K50433-025

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)

Yes

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

b46ab4d7-2a07-432c-83db-24c0bba60274

Public Version Date

October 12, 2021

Public Version Number

1

DI Record Publish Date

October 04, 2021

Package DI Number

08718375868041

Quantity per Package

8

Contains DI Package

08718375868058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf box