Catalog Number

-

Brand Name

Plus Medical Isolation Gown Level 3

Version/Model Number

PM4405FG

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

K212698,K212698

Product Code

FYC

Product Code Name

Gown, Isolation, Surgical

Public Device Record Key

9ab5e13d-7493-49e1-843f-9ad0fecf4be2

Public Version Date

March 17, 2022

Public Version Number

1

DI Record Publish Date

March 09, 2022

Package DI Number

16973062321325

Quantity per Package

10

Contains DI Package

06973062321328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-