Catalog Number

17-9936

Brand Name

DeRoyal

Version/Model Number

17-9936

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EFN

Product Code Name

COTTON, ROLL

Public Device Record Key

7564dd36-71cb-4187-8ea4-2dfea636ab64

Public Version Date

July 07, 2021

Public Version Number

1

DI Record Publish Date

June 29, 2021

Package DI Number

50749756033447

Quantity per Package

40

Contains DI Package

00749756033442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case