Catalog Number

8887648221

Brand Name

Dover

Version/Model Number

8887648221

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

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

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

5e76e805-6549-4488-876d-d0d5f498a06e

Public Version Date

December 04, 2020

Public Version Number

13

DI Record Publish Date

September 24, 2016

Package DI Number

30884521016839

Quantity per Package

10

Contains DI Package

20884521016832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK