Catalog Number

-

Brand Name

Ezy Dose

Version/Model Number

69315

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

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

HGD

Product Code Name

Applicator, Vaginal

Public Device Record Key

4e8bf01e-125e-4f1a-a5d7-dbde7c3e2a8e

Public Version Date

November 05, 2020

Public Version Number

1

DI Record Publish Date

October 28, 2020

Package DI Number

20025715693150

Quantity per Package

12

Contains DI Package

00025715693156

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER