Catalog Number

-

Brand Name

At Ease

Version/Model Number

BUSAESUWS18

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 01, 2022

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)

Yes

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

d68226a1-aea0-4637-8405-282f2829954e

Public Version Date

May 23, 2022

Public Version Number

2

DI Record Publish Date

May 01, 2020

Package DI Number

10075289621717

Quantity per Package

4

Contains DI Package

00075289621710

Package Discontinue Date

May 01, 2022

Package Status

Not in Commercial Distribution

Package Type

Case