Duns Number:254491293
Device Description: Cleaning Brush Kit - 9992 Suction Well and Valve Cleaning Brush & 9115 Channel Cleaning Br Cleaning Brush Kit - 9992 Suction Well and Valve Cleaning Brush & 9115 Channel Cleaning Brush. HIBC/UPN: M45391552
Catalog Number
9155
Brand Name
9000 Series Disposable Channel Cleaning Brush
Version/Model Number
9155
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"
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
cc884389-747e-41a9-a9f2-d7cc9b076f02
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 23, 2017
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 | 40 |