Catalog Number

HS51B, HS51BW

Brand Name

HeelShield

Version/Model Number

HS51B

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

e7dd7742-14f0-4059-b2f8-9a3fd168c8bd

Public Version Date

July 23, 2021

Public Version Number

2

DI Record Publish Date

February 20, 2019

Package DI Number

00810006680911

Quantity per Package

10

Contains DI Package

00810006680522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE