Catalog Number

Not Applicable

Brand Name

Elite Elastic Bandage

Version/Model Number

ELITE-EB002

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)

-

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

600a9ae0-ba67-4fef-bf19-222075f41649

Public Version Date

April 29, 2021

Public Version Number

1

DI Record Publish Date

April 21, 2021

Package DI Number

00840155407695

Quantity per Package

10

Contains DI Package

00840155407626

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box