Catalog Number

-

Brand Name

Abena

Version/Model Number

1000020586

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

14f59b68-dde7-4146-a0bc-435c92858b1a

Public Version Date

January 03, 2022

Public Version Number

3

DI Record Publish Date

July 10, 2020

Package DI Number

00810049810207

Quantity per Package

50

Contains DI Package

00810049810191

Package Discontinue Date

January 01, 2022

Package Status

Not in Commercial Distribution

Package Type

Case