Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

94-0268

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

5d9afce2-9fd1-4aba-b770-29c3651474f8

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

September 12, 2016

Package DI Number

50749756557264

Quantity per Package

2

Contains DI Package

00749756557269

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case