Catalog Number

NSL2-1026H

Brand Name

Nephro-Stent Nephroureteral Stent Catheter

Version/Model Number

NSL2-1026H

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

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

9c85fd10-12f1-420d-a569-b10dda93fe69

Public Version Date

March 26, 2019

Public Version Number

4

DI Record Publish Date

September 07, 2016

Package DI Number

H862NSL21026H2

Quantity per Package

4

Contains DI Package

H862NSL21026H1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper