Catalog Number

-

Brand Name

Trivarion

Version/Model Number

001-15

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"

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

09834aa4-b077-4af6-bb38-a1313690b202

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 26, 2014

Package DI Number

10859975005049

Quantity per Package

12

Contains DI Package

00859975005042

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box