Catalog Number

NCL2-1035HB-K

Brand Name

Nephro-Cath Nephrostomy Drainage Catheter

Version/Model Number

NCL2-1035HB-K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

2e8df0cc-37fc-4255-8502-6709e7cbebf4

Public Version Date

December 31, 2021

Public Version Number

3

DI Record Publish Date

October 23, 2020

Package DI Number

H862NCL21035HBKS2

Quantity per Package

10

Contains DI Package

H862NCL21035HBKS1

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

Shipper