Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

Q408

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

e1f145c3-77a0-4cf9-bc92-01d98d0e05ca

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 20, 2016

Package DI Number

30809160002944

Quantity per Package

4

Contains DI Package

20809160002947

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-