Catalog Number

597G3300

Brand Name

UNDERPAD INTEGRITY

Version/Model Number

597G3300

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"

-

For Single-Use

-

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

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Public Device Record Key

99b8e4c0-ae34-4815-86e6-499e3c4b17af

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

January 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-