Catalog Number

NCL2T-1450HB

Brand Name

Nephro-Cath Nephrostomy Drainage Catheter

Version/Model Number

NCL2T-1450HB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 27, 2022

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

67e448d1-32d6-40e6-8afc-d3e499d74230

Public Version Date

April 28, 2022

Public Version Number

2

DI Record Publish Date

June 09, 2021

Package DI Number

H862NCL2T1450HB1

Quantity per Package

5

Contains DI Package

H862NCL2T1450HB0

Package Discontinue Date

April 27, 2022

Package Status

Not in Commercial Distribution

Package Type

Dispenser