Catalog Number

NCL2-1035H

Brand Name

Nephro-Cath Nephrostomy Drainage Catheter

Version/Model Number

NCL2-1035H

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

-

Product Code

GBO

Product Code Name

Catheter, Nephrostomy, General & Plastic Surgery

Public Device Record Key

bb92d6f0-9541-4375-afda-63504232c261

Public Version Date

May 02, 2022

Public Version Number

4

DI Record Publish Date

August 29, 2016

Package DI Number

H862NCL21035H2

Quantity per Package

4

Contains DI Package

H862NCL21035H1

Package Discontinue Date

February 28, 2027

Package Status

In Commercial Distribution

Package Type

Shipper