Catalog Number

HP221P

Brand Name

Guardian Mid-Calf Heel Protector

Version/Model Number

HP211CS

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

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

b04a6b6b-238f-45b9-bed7-4e57262f09da

Public Version Date

June 29, 2021

Public Version Number

2

DI Record Publish Date

February 20, 2019

Package DI Number

00810006683202

Quantity per Package

6

Contains DI Package

00810006681963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE