Catalog Number

98302-0140-08

Brand Name

Clever Choice

Version/Model Number

SDI-ADM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

db770f26-c101-4012-abb7-a9a02ab31613

Public Version Date

January 13, 2021

Public Version Number

1

DI Record Publish Date

January 05, 2021

Package DI Number

10898302140084

Quantity per Package

6

Contains DI Package

00898302140087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case