Duns Number:243880700
Device Description: 5 MM CYLINDRICAL BRUSHES, LENGTH: 90"/230cm, BRUSH LENGTH: 0.79"/20mm, BRUSH (±): 0.20"/5m 5 MM CYLINDRICAL BRUSHES, LENGTH: 90"/230cm, BRUSH LENGTH: 0.79"/20mm, BRUSH (±): 0.20"/5mm, SHEATH (±): 0.073"/1.75mm, BRUSH ENDS: 2, METALLIC GREY DELRIN
Catalog Number
300-23050-2
Brand Name
Batrik Brush/Cyl/Gry/TD-1.75/OL-230cm
Version/Model Number
300-23050-2
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)
-
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
3bd11ba2-465f-4030-bdbc-416361e8879c
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
November 11, 2021
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 | 748 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |