Catalog Number

NCL2-0835HB-KSA

Brand Name

Nephro-Cath Nephrostomy Drainage Catheter

Version/Model Number

NCL2-0835HB-KSA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 05, 2017

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

edbb06b2-66e7-417a-bd00-f45f9f06afbe

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 05, 2016

Package DI Number

H862NCL20835HBKSA2

Quantity per Package

5

Contains DI Package

H862NCL20835HBKSA0

Package Discontinue Date

January 05, 2017

Package Status

Not in Commercial Distribution

Package Type

Shipper