Catalog Number

-

Brand Name

MedSource Isolation Gown

Version/Model Number

MS-31575

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

4cd68104-a4d9-47c9-b383-1c8df505f0ba

Public Version Date

June 10, 2021

Public Version Number

1

DI Record Publish Date

June 02, 2021

Package DI Number

00840155400641

Quantity per Package

100

Contains DI Package

00840155408876

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case