Catalog Number

-

Brand Name

Protect U Guard CPE Isolation Gown

Version/Model Number

P10505

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

FYE

Product Code Name

Dress, Surgical

Public Device Record Key

a45ba7a0-a061-4b35-a080-c209225048d3

Public Version Date

February 10, 2021

Public Version Number

1

DI Record Publish Date

February 02, 2021

Package DI Number

B086205052

Quantity per Package

75

Contains DI Package

B086105051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON