Catalog Number

31-657

Brand Name

DeRoyal

Version/Model Number

31-657

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

IPM

Product Code Name

COVER, LIMB

Public Device Record Key

6a0f6e44-cb6c-4937-b7a0-4316b43164a1

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Package DI Number

50749756031078

Quantity per Package

50

Contains DI Package

00749756031073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case