Catalog Number

-

Brand Name

Poise

Version/Model Number

Pessary

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

HHW

Product Code Name

PESSARY, VAGINAL

Public Device Record Key

91112abc-05f5-4fa4-98fe-123d94a4ad70

Public Version Date

April 15, 2019

Public Version Number

1

DI Record Publish Date

April 05, 2019

Package DI Number

10036000465607

Quantity per Package

4

Contains DI Package

00036000465600

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case