Catalog Number

-

Brand Name

Best Choice

Version/Model Number

BUSBCSUWR18

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)

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

214e1e47-5382-4c7f-a438-6d7c2fce1479

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Package DI Number

10070038598784

Quantity per Package

4

Contains DI Package

00070038598787

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE