Duns Number:627879687
Device Description: Revital-Ox All-In-One Channel and Valve Control Brush support effective cleaning inside lu Revital-Ox All-In-One Channel and Valve Control Brush support effective cleaning inside lumened instruments with the control of a flexible stainless steel handle delivering control while gentle nylon bristles dislodge bioburden from hard to reach interior channels.
Catalog Number
2D77QH
Brand Name
Revital-Ox
Version/Model Number
2D77QH
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
3bcec852-9cf8-4a04-89a7-e4d7c0297dbb
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 31, 2021
Package DI Number
50724995002058
Quantity per Package
100
Contains DI Package
00724995002053
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |