Catalog Number

1534

Brand Name

Sure Care

Version/Model Number

1534

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

6a2242ad-8eac-43d3-b9e6-79d0e6d1ba9d

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 22, 2018

Package DI Number

10884527000999

Quantity per Package

72

Contains DI Package

20884527000996

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE