Catalog Number

242218NA

Brand Name

Actreen®

Version/Model Number

242218NA

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

1457f6c5-5f7e-4985-8074-60ff2f10fb76

Public Version Date

December 10, 2021

Public Version Number

3

DI Record Publish Date

March 03, 2019

Package DI Number

04046955196753

Quantity per Package

14

Contains DI Package

04046955196746

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton