Catalog Number

-

Brand Name

Poise

Version/Model Number

Pessary

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2021

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

HHW

Product Code Name

PESSARY, VAGINAL

Public Device Record Key

d69ebc41-1962-483c-b76f-e3bf6f6ac5f8

Public Version Date

September 30, 2021

Public Version Number

3

DI Record Publish Date

April 05, 2019

Package DI Number

10036000465591

Quantity per Package

4

Contains DI Package

00036000465594

Package Discontinue Date

September 30, 2021

Package Status

Not in Commercial Distribution

Package Type

Case