Catalog Number

NCP-1035HB

Brand Name

Nephro-Cath Nephrostomy Drainage Catheter

Version/Model Number

NCP-1035HB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2018

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

028a7be5-9bf7-4e06-8b07-c66b41acb11a

Public Version Date

January 28, 2019

Public Version Number

3

DI Record Publish Date

September 06, 2016

Package DI Number

H862NCP1035HB2

Quantity per Package

4

Contains DI Package

H862NCP1035HB1

Package Discontinue Date

April 25, 2018

Package Status

Not in Commercial Distribution

Package Type

Shipper