Catalog Number

HNM-36-150559

Brand Name

HNM Women Care

Version/Model Number

HNM-36-150559

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092981

Product Code

HHW

Product Code Name

Pessary, Vaginal

Public Device Record Key

8a8e1840-e637-44fe-8f0b-25fc39c8edd1

Public Version Date

May 08, 2019

Public Version Number

1

DI Record Publish Date

April 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-