Catalog Number

1100B

Brand Name

Sure Care

Version/Model Number

1100B

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

7f8ab30f-42ae-48e3-8c4c-3bbb369290d8

Public Version Date

May 06, 2021

Public Version Number

3

DI Record Publish Date

June 22, 2018

Package DI Number

20884527021991

Quantity per Package

132

Contains DI Package

10884527021994

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE