Catalog Number

-

Brand Name

Wallace Ring Pessary PVC, 110 mm

Version/Model Number

700/300/110

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"

Yes

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

K012277,K012277

Product Code

HHW

Product Code Name

Pessary, Vaginal

Public Device Record Key

e7ef1fac-df54-4261-acd1-d22510e3674e

Public Version Date

January 28, 2020

Public Version Number

1

DI Record Publish Date

January 20, 2020

Package DI Number

20888937020889

Quantity per Package

20

Contains DI Package

00888937020885

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box