Catalog Number

-

Brand Name

UR-Assure

Version/Model Number

05001-00-MCF

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NOA

Product Code Name

Device, Paste-On For Incontinence, Non-Sterile

Public Device Record Key

1aad356c-de76-46ff-a01b-7b363b101d31

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

October 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-