Duns Number:604056226
Device Description: Endoscope Brush, Brush Kit, Colonoscope, Double-Ended + Channel Brushes
Catalog Number
-
Brand Name
Key Surgical Endoscope Brushes
Version/Model Number
EB10107C
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)
-
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
5b7d6d8b-f886-451f-b290-b65185224fab
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
January 31, 2020
Package DI Number
10849771040566
Quantity per Package
4
Contains DI Package
00849771040569
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |