Duns Number:315304071
Device Description: SENSOR-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.6Fr, working chann SENSOR-URETERORENOSCOPE 9.9FR WL 680MM flexible, working channel 1: 3.6Fr, working channel 2: 2.4Fr, double slanted distal tip Ø 5,2Fr, TL 980mm, deflection +270°/-270°, laser shifter for laser fiber fixation and guidance, locking lever for the distal tip, two function buttons, for connection to ENDOCAM Logic HD, LED-illumination, distal Sensor, Fixfocus
Catalog Number
7356071US
Brand Name
COBRA VISION
Version/Model Number
7356071US
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
-
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
FGA
Product Code Name
Kit, nephroscope
Public Device Record Key
b0390d6f-1a05-44c3-bf85-01a2356a8f61
Public Version Date
August 16, 2021
Public Version Number
2
DI Record Publish Date
July 15, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |