Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS6001A

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

872948f0-55a7-4f36-9e6b-289db609c200

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

10849027000672

Quantity per Package

8

Contains DI Package

00849027000675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case