Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

53245

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 16, 2021

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

FQM

Product Code Name

BANDAGE, ELASTIC

Public Device Record Key

5ec264ad-c282-4237-9920-ea24ea91d9c4

Public Version Date

September 20, 2021

Public Version Number

3

DI Record Publish Date

December 30, 2019

Package DI Number

20809160274832

Quantity per Package

12

Contains DI Package

10809160274835

Package Discontinue Date

August 16, 2021

Package Status

Not in Commercial Distribution

Package Type

-