Catalog Number

-

Brand Name

MediChoice

Version/Model Number

181103

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)

-

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

b0509b1f-b77f-4562-b356-79c26cb6ea45

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Package DI Number

50885632104006

Quantity per Package

4

Contains DI Package

30885632104002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-