Catalog Number

-

Brand Name

Poise

Version/Model Number

Pessary

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 16, 2019

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

f6148147-33cc-4cad-a32e-d64c96ef39cf

Public Version Date

May 16, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-