Catalog Number

-

Brand Name

Clarity RMS Console

Version/Model Number

ASY00015

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

-

For Single-Use

-

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

EXY

Product Code Name

Uroflowmeter

Public Device Record Key

cc1c5b8e-8bbb-4108-9dac-5f22cc13fd2c

Public Version Date

October 10, 2019

Public Version Number

1

DI Record Publish Date

October 02, 2019

Package DI Number

17290016022022

Quantity per Package

1

Contains DI Package

07290016022025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box