Catalog Number

8887605262

Brand Name

Dover

Version/Model Number

8887605262

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

18653312-ea8b-4e2d-a0f8-09a2bb829037

Public Version Date

February 23, 2021

Public Version Number

12

DI Record Publish Date

September 24, 2016

Package DI Number

30884521016891

Quantity per Package

6

Contains DI Package

20884521016894

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE