Duns Number:801895244
Device Description: Cystoscopy kit, flexible cystoscopy cannula and sterile drape, 10 of each
Catalog Number
-
Brand Name
Endosee Cystoscopy Kit
Version/Model Number
OR-ESCX10KIT
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
K170660
Product Code
FAJ
Product Code Name
Cystoscope And Accessories, Flexible/Rigid
Public Device Record Key
4784c73e-8541-4ce4-b8ba-7b1e75fa1642
Public Version Date
February 06, 2020
Public Version Number
2
DI Record Publish Date
November 09, 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |