Catalog Number

7025-2020

Brand Name

n-Able Cath™

Version/Model Number

7025-2020

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

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

ae16aef5-f62f-4014-87f7-95de2f8fb243

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 28, 2016

Package DI Number

00851847007024

Quantity per Package

12

Contains DI Package

00851847007017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 12 inner box