Catalog Number

HF01

Brand Name

Disposable Surgical Gown

Version/Model Number

HF01

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

2448b853-49fc-4aa8-93a2-b68141defdca

Public Version Date

April 19, 2021

Public Version Number

2

DI Record Publish Date

April 08, 2021

Package DI Number

06970145500441

Quantity per Package

50

Contains DI Package

16970145500448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag