Catalog Number

8884731300

Brand Name

Dover

Version/Model Number

8884731300

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EXJ

Product Code Name

DEVICE, INCONTINENCE, UROSHEATH TYPE, STERILE

Public Device Record Key

27bde269-cb3e-4eab-8e7a-432ab332dc57

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

10884521003989

Quantity per Package

144

Contains DI Package

20884521003986

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE