Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

ORT-400W

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 03, 2020

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

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

584b981b-707d-4479-a501-bfd6a1b4f9ae

Public Version Date

March 25, 2020

Public Version Number

3

DI Record Publish Date

August 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-