Catalog Number

-

Brand Name

AdvanTrode

Version/Model Number

WF47

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 05, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070807,K070807

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

71c9098f-fee4-4bcc-a9b9-1e3b77e8edec

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

October 05, 2016

Package DI Number

00677346320446

Quantity per Package

10

Contains DI Package

00677346310447

Package Discontinue Date

February 05, 2019

Package Status

Not in Commercial Distribution

Package Type

Bag