Catalog Number

1547

Brand Name

Sure Care

Version/Model Number

1547

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

KME

Product Code Name

BEDDING, DISPOSABLE, MEDICAL

Public Device Record Key

a0c06f9e-6228-4f59-b081-c6261c41c74f

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 22, 2018

Package DI Number

10884527001316

Quantity per Package

90

Contains DI Package

20884527001313

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE