Catalog Number

5359-24

Brand Name

ELBOW PAD

Version/Model Number

5359-1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

5e5dfac7-60c2-4e09-a574-8203c23b5268

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Package DI Number

10842430108973

Quantity per Package

24

Contains DI Package

00842430108976

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

multi-pack