Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS6003A

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

IPR

Product Code Name

Crutch

Public Device Record Key

5de3c4f1-3be1-4f96-a94e-c1de0e6f6e13

Public Version Date

September 10, 2020

Public Version Number

1

DI Record Publish Date

September 02, 2020

Package DI Number

10849027000696

Quantity per Package

8

Contains DI Package

00849027000699

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case