Duns Number:942192550
Device Description: CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using addit CYSTOSCOPEMediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures.HYSTEROSCOPEMediVision Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery.
Catalog Number
MV2930
Brand Name
MEDIVISION
Version/Model Number
MV2930
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)
Yes
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
f46ac9c3-18a0-4dfc-a3fc-2d059eae97ec
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
December 14, 2016
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. | 25 |