Duns Number:030650113
Device Description: Heavy Duty Combination Endoscope Cleaning Brush
Catalog Number
1200-09
Brand Name
CleanFreak®
Version/Model Number
1200-09
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
a727ddbb-5915-4dc5-a4f2-1b9b82e0f3ea
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 17, 2016
Package DI Number
M7831200091
Quantity per Package
50
Contains DI Package
M7831200090
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |