Catalog Number

8887665241

Brand Name

Dover

Version/Model Number

8887665241

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Public Device Record Key

c43e028e-c191-44f6-a75c-9c1da434ddd8

Public Version Date

December 04, 2020

Public Version Number

11

DI Record Publish Date

September 24, 2016

Package DI Number

20884521017037

Quantity per Package

60

Contains DI Package

10884521017030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE