Catalog Number

-

Brand Name

ZD Isolation Gown-C

Version/Model Number

ZDB120018

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)

Yes

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

d4633047-8cb8-4392-b258-db97c590b07a

Public Version Date

June 23, 2020

Public Version Number

1

DI Record Publish Date

June 15, 2020

Package DI Number

06971004783135

Quantity per Package

10

Contains DI Package

06971004783128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case