Catalog Number

-

Brand Name

Henry Schein

Version/Model Number

Model HS60-3050-B

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

27188461-f599-4258-b5c7-98ffc2bd1c57

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Package DI Number

26931918191529

Quantity per Package

10

Contains DI Package

16931918191522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton