Catalog Number

HC 80TT-120-001

Brand Name

Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V

Version/Model Number

HC 80TT-120-001

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190005

Product Code

MLR

Product Code Name

Sterilizer, Chemical

Public Device Record Key

f88961c0-953f-452c-aaf7-010ac999ee6f

Public Version Date

May 06, 2020

Public Version Number

1

DI Record Publish Date

April 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-