Duns Number:071595540
Device Description: G/D 4mm Cleaning Brush
Catalog Number
474
Brand Name
CONMED
Version/Model Number
474
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"
-
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
3aa1e49c-44f4-4db5-905f-f03ba31417db
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 29, 2020
Package DI Number
10653405050384
Quantity per Package
50
Contains DI Package
30653405050388
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |