Catalog Number

NC89189

Brand Name

ActivaPatch IontoGo 4.0

Version/Model Number

001-50

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

EGJ

Product Code Name

Device, Iontophoresis, Other Uses

Public Device Record Key

7973949d-0411-49a5-8991-def6aa52c401

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 14, 2016

Package DI Number

10859975005209

Quantity per Package

40

Contains DI Package

00859975005202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case