Catalog Number

9865-00

Brand Name

DeRoyal

Version/Model Number

9865-00

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

FQM

Product Code Name

BANDAGE, ELASTIC

Public Device Record Key

6f8435e4-9af3-4793-b05b-8f5e9c68dd71

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

July 09, 2021

Package DI Number

50749756024247

Quantity per Package

20

Contains DI Package

00749756024242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case