Catalog Number

HS51S, HS51SW

Brand Name

HeelShield

Version/Model Number

HS51S

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

b5a88923-4e9e-4b1c-a914-bf5e52635f85

Public Version Date

July 23, 2021

Public Version Number

2

DI Record Publish Date

February 20, 2019

Package DI Number

00810006680928

Quantity per Package

12

Contains DI Package

00810006680539

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE