Catalog Number

87200121

Brand Name

Zimmertrodes

Version/Model Number

87200121

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"

Yes

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

3db09b6a-93bd-44d8-aeec-c92215d96f78

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

34053815054406

Quantity per Package

5

Contains DI Package

24053815054409

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case