Catalog Number

155731

Brand Name

Dover

Version/Model Number

155731

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FCE

Product Code Name

Enema kit

Public Device Record Key

484ee2cd-880a-44e0-9364-ce9ad548e7af

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 29, 2018

Package DI Number

20884521004396

Quantity per Package

50

Contains DI Package

10884521004399

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE