Catalog Number

5558492038

Brand Name

Dover

Version/Model Number

5558492038

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

-

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

K810216,K810216

Product Code

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

6be12bb0-3a91-48cc-8456-9cbae9e453e4

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-