Catalog Number

-

Brand Name

N/A

Version/Model Number

EP4070WCD

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

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

35fa2be9-7010-4cbc-b380-f635f57b4e73

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

October 18, 2016

Package DI Number

80092237605772

Quantity per Package

200

Contains DI Package

10092237600105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA