Catalog Number

-

Brand Name

KATANA Cleaner

Version/Model Number

#3970-KA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191133

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

703604d8-b105-4c14-b002-0df570ea5a7b

Public Version Date

August 10, 2021

Public Version Number

2

DI Record Publish Date

December 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-