Catalog Number

-

Brand Name

AdvanTrode

Version/Model Number

BST13

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070807,K070807,K070807

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

a190e4b4-3cc6-4fef-a93b-995346365b88

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

October 05, 2016

Package DI Number

00677346320514

Quantity per Package

10

Contains DI Package

00677346310515

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag