Catalog Number

1201-20

Brand Name

CleanFreak®

Version/Model Number

1201-20

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"

Yes

For Single-Use

Yes

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

-

Product Code

MNL

Product Code Name

Accessories, Cleaning Brushes, For Endoscope

Public Device Record Key

1ba484ca-9994-4f4c-b439-64d3a5cb8f0d

Public Version Date

June 29, 2020

Public Version Number

5

DI Record Publish Date

September 17, 2016

Package DI Number

M7831201201

Quantity per Package

24

Contains DI Package

M7831201200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case