Catalog Number

NA – LUCM1

Brand Name

Lucid Transcranial Doppler System

Version/Model Number

M1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 10, 2020

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"

-

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

K160442

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

4ad7d5ea-de46-4a4a-b6dd-942055cb6211

Public Version Date

August 19, 2022

Public Version Number

6

DI Record Publish Date

May 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-