Duns Number:801895244
Device Description: Cystoscopy cannula, operating room
Catalog Number
-
Brand Name
Endosee Cystoscopy Cannula
Version/Model Number
OR-ESCX5
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,K170660
Product Code
FAJ
Product Code Name
Cystoscope And Accessories, Flexible/Rigid
Public Device Record Key
b7772e80-9ec9-44db-8466-289a9a90007e
Public Version Date
December 10, 2018
Public Version Number
1
DI Record Publish Date
November 09, 2018
Package DI Number
20888937022463
Quantity per Package
5
Contains DI Package
00888937022469
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |