Catalog Number

UR208

Brand Name

Uresta®

Version/Model Number

UR208

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

-

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

K083769,K083769,K083769

Product Code

HHW

Product Code Name

Pessary, Vaginal

Public Device Record Key

23b03377-b336-4844-a1c8-e9fe5d799817

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

November 23, 2020

Package DI Number

10692379000261

Quantity per Package

6

Contains DI Package

00692379000264

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-