Catalog Number

-

Brand Name

Abena

Version/Model Number

1000021166

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

EYQ

Product Code Name

Garment, Protective, For Incontinence

Public Device Record Key

729e69cb-ca42-40bb-9e12-30e52591572c

Public Version Date

August 11, 2022

Public Version Number

1

DI Record Publish Date

August 03, 2022

Package DI Number

05713571001578

Quantity per Package

4

Contains DI Package

05713571001561

Package Discontinue Date

January 01, 2023

Package Status

In Commercial Distribution

Package Type

Case