Catalog Number

HP301

Brand Name

Economy Foam Heel Protector

Version/Model Number

HP301

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ILZ

Product Code Name

Accessories, Traction

Public Device Record Key

58f35080-75ab-4b9e-83b8-7afad2e947cd

Public Version Date

August 03, 2021

Public Version Number

1

DI Record Publish Date

July 26, 2021

Package DI Number

10810006683513

Quantity per Package

12

Contains DI Package

00810006683516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pair