Catalog Number

8887606203

Brand Name

Dover

Version/Model Number

8887606203

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

FCM

Product Code Name

Tray, catheterization, sterile urethral, with or without catheter (kit)

Public Device Record Key

17adcc6f-bc31-470b-ac0d-edf0da7a18f0

Public Version Date

February 23, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521009759

Quantity per Package

20

Contains DI Package

10884521009752

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE