Duns Number:315304071
Device Description: SENSOR-CYSTOSCOPE 16.2FR WL 400MM flexible, working channel 7,5FR, slanted distal tip, TL SENSOR-CYSTOSCOPE 16.2FR WL 400MM flexible, working channel 7,5FR, slanted distal tip, TL 660mm, deflection +210°/-210°, two function buttons, control lever to distal – upward DEF, for connection to ENDOCAM Logic HD and ENDOCAM Logic HD lite 5525, LED-illumination, distal Sensor, Fixfocus
Catalog Number
7315006
Brand Name
MAMBA VISION
Version/Model Number
7315006
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
FAJ
Product Code Name
Cystoscope and accessories, flexible/rigid
Public Device Record Key
75e05619-7f66-448e-ad9a-5e4af96b418c
Public Version Date
April 23, 2021
Public Version Number
6
DI Record Publish Date
April 10, 2018
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 |