Catalog Number

4608661-02

Brand Name

Exadoral®

Version/Model Number

4608661-02

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYX

Product Code Name

DISPENSER, LIQUID MEDICATION

Public Device Record Key

6eb6c6ad-6e35-4aef-bbd1-88005d2a55ed

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

04046964723759

Quantity per Package

18

Contains DI Package

04046964723742

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton