Catalog Number

HD-396-0911

Brand Name

DeRoyal

Version/Model Number

HD-396-0911

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

NNI

Product Code Name

CONTAINER, SPECIMEN, NON-STERILE

Public Device Record Key

afc36dc3-270a-4ff0-b823-f7513f7bdade

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

June 23, 2021

Package DI Number

50749756686308

Quantity per Package

150

Contains DI Package

00749756686303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case