Duns Number:544581269
Device Description: The video processor is used with the Single Use Flexible Ureterorenoscope designed by ANQI The video processor is used with the Single Use Flexible Ureterorenoscope designed by ANQING during minimally invasive surgery. The video processor provides power and processes the images for medical electronic endoscope.
Catalog Number
-
Brand Name
DOS
Version/Model Number
EOB-B-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 2022
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
-
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
FGB
Product Code Name
Ureteroscope And Accessories, Flexible/Rigid
Public Device Record Key
7567d010-aa97-464c-b441-86aa20cc56e3
Public Version Date
October 17, 2022
Public Version Number
5
DI Record Publish Date
January 10, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |