Catalog Number

-

Brand Name

McKesson

Version/Model Number

4822

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

-

Product Code

NOA

Product Code Name

Device, Paste-On For Incontinence, Non-Sterile

Public Device Record Key

ce3864e0-0015-4a7b-97a8-03e73def608f

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

June 25, 2020

Package DI Number

20612479188741

Quantity per Package

50

Contains DI Package

10612479189178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box