Catalog Number

EBV2

Brand Name

DeRoyal

Version/Model Number

EBV2

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

-

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

b9a4dbe1-e953-484c-b3ba-b4b5aaa04dbe

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

August 03, 2021

Package DI Number

50749756140879

Quantity per Package

10

Contains DI Package

00749756140874

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case