Catalog Number

NSL2T-1022H

Brand Name

Nephro-Stent Nephroureteral Stent Catheter

Version/Model Number

NSL2T-1022H

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 28, 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

K980889,K980889,K980889

Product Code

LJE

Product Code Name

Catheter, Nephrostomy

Public Device Record Key

1f55f444-659e-44ba-9353-29f3d9e8ebaf

Public Version Date

April 29, 2022

Public Version Number

2

DI Record Publish Date

June 09, 2021

Package DI Number

H862NSL2T1022H1

Quantity per Package

5

Contains DI Package

H862NSL2T1022H0

Package Discontinue Date

April 28, 2022

Package Status

Not in Commercial Distribution

Package Type

Dispenser