Catalog Number

31-VIAL19

Brand Name

DeRoyal

Version/Model Number

31-VIAL19

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

JSG

Product Code Name

CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Public Device Record Key

41387f4c-2583-4f5a-9c43-b616160b8ff1

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Package DI Number

50749756372744

Quantity per Package

50

Contains DI Package

00749756372749

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case