Catalog Number

PPSS281445

Brand Name

Preventive Pad

Version/Model Number

PPSS281445

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

eb17276a-3284-47ae-8f53-cc61f5b6297b

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 20, 2019

Package DI Number

00810006683295

Quantity per Package

10

Contains DI Package

00810006682137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE