Duns Number:342243334
Device Description: Cutt. loop saline-resectoscopy electroderetrograde,24Ch.
Catalog Number
36.010.24SL
Brand Name
Cutt. loop saline-resectoscopy electrode retrograde,24Ch.
Version/Model Number
36.010.24SL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
FDC
Product Code Name
RESECTOSCOPE, WORKING ELEMENT
Public Device Record Key
c2326449-6e6e-4572-8d7c-7caa1bbc8c48
Public Version Date
June 05, 2020
Public Version Number
3
DI Record Publish Date
September 28, 2017
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 | 19 |
2 | A medical device with a moderate to high risk that requires special controls. | 1976 |