Catalog Number

-

Brand Name

Abena

Version/Model Number

2594

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

-

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

EYQ

Product Code Name

Garment, Protective, For Incontinence

Public Device Record Key

9810abfa-5f3b-44f9-b73c-6e165ba4e09e

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

March 05, 2020

Package DI Number

00190509001681

Quantity per Package

24

Contains DI Package

00190509001629

Package Discontinue Date

January 01, 2022

Package Status

Not in Commercial Distribution

Package Type

Case