Catalog Number

-

Brand Name

n.a.

Version/Model Number

20-21-080-1

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

278d476d-68c3-4fac-b12f-d878777075db

Public Version Date

June 12, 2020

Public Version Number

1

DI Record Publish Date

June 04, 2020

Package DI Number

14250105606550

Quantity per Package

10

Contains DI Package

04250105606553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-