Catalog Number

9378-01

Brand Name

DeRoyal

Version/Model Number

9378-01

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

-

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

IME

Product Code Name

Pack, hot or cold, reusable

Public Device Record Key

b5674624-ed66-4dea-98e4-dcac6efaf638

Public Version Date

August 06, 2021

Public Version Number

1

DI Record Publish Date

July 29, 2021

Package DI Number

50749756672509

Quantity per Package

48

Contains DI Package

00749756672504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case