Catalog Number

87200172

Brand Name

Zimmertrodes

Version/Model Number

87200172

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

K140340,K140340,K140340,K140340

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

ca29b4ce-4b90-4c78-b9ce-461b7bda481d

Public Version Date

March 18, 2021

Public Version Number

1

DI Record Publish Date

March 10, 2021

Package DI Number

24053815072922

Quantity per Package

8

Contains DI Package

14053815072925

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box