Duns Number:711789789
Device Description: BW-412T DISP COMBO CLEANING BRUSH
Catalog Number
-
Brand Name
Single Use Combination Cleaning Brush
Version/Model Number
BW-412T
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
54d7cb18-2755-4b14-b810-c4eb147b3ce6
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2018
Package DI Number
54953170297422
Quantity per Package
4
Contains DI Package
04953170297427
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |