Catalog Number

9999-28

Brand Name

DeRoyal

Version/Model Number

9999-28

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

428c775e-365b-4de1-99f8-fdb603a67681

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

Package DI Number

50749756815012

Quantity per Package

20

Contains DI Package

00749756815017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case