Catalog Number

-

Brand Name

Abena

Version/Model Number

1000020770

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2023

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

eed42d24-28a0-43f5-ae63-bce84b0c6cf8

Public Version Date

January 03, 2022

Public Version Number

3

DI Record Publish Date

August 26, 2020

Package DI Number

06971004783074

Quantity per Package

10

Contains DI Package

06971004783067

Package Discontinue Date

January 01, 2022

Package Status

Not in Commercial Distribution

Package Type

Case