Duns Number:192559557
Device Description: HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER WITH DEPTH MARKS, LONG, 8F
Catalog Number
NCL2T-0850HB
Brand Name
Nephro-Cath Nephrostomy Drainage Catheter
Version/Model Number
NCL2T-0850HB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 27, 2022
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
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
-
Product Code
GBO
Product Code Name
Catheter, Nephrostomy, General & Plastic Surgery
Public Device Record Key
e5325142-0489-4d57-a4dd-1664948fa6ff
Public Version Date
April 28, 2022
Public Version Number
2
DI Record Publish Date
June 09, 2021
Package DI Number
H862NCL2T0850HB1
Quantity per Package
5
Contains DI Package
H862NCL2T0850HB0
Package Discontinue Date
April 27, 2022
Package Status
Not in Commercial Distribution
Package Type
Dispenser
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 179 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |
U | Unclassified | 24 |