Duns Number:076769355
Device Description: A device used to remove dirt or debris from the working channel(s) of the endoscope prior A device used to remove dirt or debris from the working channel(s) of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube with plastic bristles. This is a single-use device.
Catalog Number
4665
Brand Name
Good Bi-Brush
Version/Model Number
4665
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
K933354,K933354
Product Code
FEB
Product Code Name
Accessories, Cleaning, For Endoscope
Public Device Record Key
20cb8285-1379-4684-9df4-b61c39949f60
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |