Catalog Number

-

Brand Name

BeneCath®

Version/Model Number

NCW08M

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

c2be19f2-defe-48c5-b5ff-f2d04bae75c6

Public Version Date

December 25, 2020

Public Version Number

3

DI Record Publish Date

November 10, 2020

Package DI Number

06972624970011

Quantity per Package

30

Contains DI Package

16972624970018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX