Catalog Number

-

Brand Name

Protect U Guard Silicone Foam Sterile Dressing

Version/Model Number

P19132

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

eaf18f4a-21fc-461e-8b75-4f6ff4ed8586

Public Version Date

June 22, 2021

Public Version Number

2

DI Record Publish Date

August 21, 2020

Package DI Number

B086291322

Quantity per Package

360

Contains DI Package

B086191321

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON