Catalog Number

NSL2T-0828H

Brand Name

Nephro-Stent Nephroureteral Stent Catheter

Version/Model Number

NSL2T-0828H

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

02a15991-9fc6-4a5d-974a-8cbbaf2044c7

Public Version Date

May 06, 2022

Public Version Number

1

DI Record Publish Date

April 28, 2022

Package DI Number

10817640020193

Quantity per Package

5

Contains DI Package

00817640020196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser