Catalog Number

002-0396-00

Brand Name

SpeedClean

Version/Model Number

002-0396-00

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K023348,K023348

Product Code

FLE

Product Code Name

Sterilizer, Steam

Public Device Record Key

14fbfb30-33f0-409b-b156-9efcb512335f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

10841709100205

Quantity per Package

12

Contains DI Package

00841709100208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box