Duns Number:627879687
Device Description: The Gemini-Double Ended Channel cleaning brush is a nylon Flexi Brush attached to a flexib The Gemini-Double Ended Channel cleaning brush is a nylon Flexi Brush attached to a flexible plastic sheath designed to safely remove debris from flexible endoscopes.
Catalog Number
00711627
Brand Name
Gemini
Version/Model Number
00711627
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)
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
2e01cb95-60ef-4d87-9639-9f3bd205b6b6
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 31, 2021
Package DI Number
10724995185050
Quantity per Package
100
Contains DI Package
00724995185053
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 |