Catalog Number

23246A

Brand Name

Sure Care

Version/Model Number

23246A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 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)

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

663e8c7b-8cb3-4c2d-b203-f3196e1386ac

Public Version Date

May 06, 2021

Public Version Number

3

DI Record Publish Date

June 22, 2018

Package DI Number

20884527021984

Quantity per Package

84

Contains DI Package

10884527021987

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE