Catalog Number

400P40

Brand Name

DeRoyal

Version/Model Number

400P40

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

FMQ

Product Code Name

Restraint, protective

Public Device Record Key

2a5f1e85-72eb-4736-81f5-2e30fab74c48

Public Version Date

August 02, 2021

Public Version Number

1

DI Record Publish Date

July 23, 2021

Package DI Number

50749756816842

Quantity per Package

12

Contains DI Package

00749756816847

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case