Catalog Number

-

Brand Name

Abena

Version/Model Number

9386

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

70384235-91ce-4b3d-a736-4023dc77cd42

Public Version Date

January 03, 2022

Public Version Number

3

DI Record Publish Date

March 01, 2020

Package DI Number

05710811008205

Quantity per Package

4

Contains DI Package

05710811938601

Package Discontinue Date

January 01, 2022

Package Status

Not in Commercial Distribution

Package Type

Case