Catalog Number

NCL2-1035HB-K

Brand Name

Nephro-Cath Nephrostomy Drainage Catheter

Version/Model Number

NCL2-1035HB-K

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

8831fb47-c3b8-4225-baeb-2f03eb87af81

Public Version Date

June 16, 2021

Public Version Number

1

DI Record Publish Date

June 08, 2021

Package DI Number

20817640020152

Quantity per Package

5

Contains DI Package

10817640020155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper