Catalog Number

-

Brand Name

Plus Medical Cover Gown

Version/Model Number

PM4404PG

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K213177,K213177

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

1738b96a-68a2-4981-9cf6-d4d3c9161e01

Public Version Date

May 25, 2022

Public Version Number

1

DI Record Publish Date

May 17, 2022

Package DI Number

16973062321394

Quantity per Package

50

Contains DI Package

06973062321397

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-