Duns Number:243880700
Device Description: 5/6 MM TAPERED BRUSHES, LENGTH: 90"/230cm, BRUSH LENGTH: 0.79"/20mm, BRUSH (±): 0.20-0.24" 5/6 MM TAPERED BRUSHES, LENGTH: 90"/230cm, BRUSH LENGTH: 0.79"/20mm, BRUSH (±): 0.20-0.24"/5-6mm, SHEATH (±): 0.070"/1.75mm, BRUSH ENDS: 1, METALLIC GREY DELRIN
Catalog Number
322-23056
Brand Name
Batrik Arc Channel Brushes
Version/Model Number
322-23056
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
1f1c1d7e-46df-450b-bfb8-72680749b0bd
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 25, 2020
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 |