Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

511388

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

8cf66e61-3594-4d07-9adc-7884210fa90e

Public Version Date

April 02, 2020

Public Version Number

1

DI Record Publish Date

March 25, 2020

Package DI Number

M7525113885

Quantity per Package

100

Contains DI Package

M7525113880

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box