Catalog Number

PM4-88335

Brand Name

Overhead Cover Gown

Version/Model Number

Blue

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"

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

FME

Product Code Name

Gown, Examination

Public Device Record Key

f45c4b08-6025-4bf6-af02-cee2cf27cc90

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

10842942013949

Quantity per Package

6

Contains DI Package

00842942013942

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case