Duns Number:192559557
Device Description: HYDROPHILIC COATED NEPHROURETERAL STENT CATHETER, 8F, 24 cm Pig-to-Pig
Catalog Number
NSL2-0824H
Brand Name
Nephro-Stent Nephroureteral Stent Catheter
Version/Model Number
NSL2-0824H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 28, 2027
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
K980889,K980889,K980889
Product Code
LJE
Product Code Name
Catheter, Nephrostomy
Public Device Record Key
cadb48c0-b48a-4194-b52b-b467b7ecb033
Public Version Date
May 02, 2022
Public Version Number
5
DI Record Publish Date
September 06, 2016
Package DI Number
H862NSL20824H2
Quantity per Package
4
Contains DI Package
H862NSL20824H1
Package Discontinue Date
February 28, 2027
Package Status
In Commercial Distribution
Package Type
Shipper
| 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 |