Catalog Number

NC89188

Brand Name

ActivaPatch

Version/Model Number

001-40

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

031e3514-efad-4ee3-b524-f9d5345d842a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 22, 2016

Package DI Number

10859975005216

Quantity per Package

40

Contains DI Package

00859975005219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton