Catalog Number

46-950

Brand Name

DeRoyal

Version/Model Number

46-950

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, wound, occlusive

Public Device Record Key

c594cc5c-0960-4159-8f7d-ca25a658248d

Public Version Date

August 13, 2021

Public Version Number

1

DI Record Publish Date

August 05, 2021

Package DI Number

50749756865383

Quantity per Package

30

Contains DI Package

00749756865388

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case