Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS0031

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 27, 2020

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Public Device Record Key

aec41eca-4e48-428b-be19-2526cd648789

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

January 13, 2017

Package DI Number

10849027003659

Quantity per Package

2000

Contains DI Package

00849027003652

Package Discontinue Date

March 27, 2020

Package Status

Not in Commercial Distribution

Package Type

Case