Catalog Number

8008690

Brand Name

Logicon Caries Detector

Version/Model Number

Logicon Caries Detector

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MYN

Product Code Name

Analyzer,medical image

Public Device Record Key

f01565f6-0db2-49e0-8220-a859d7d1856a

Public Version Date

March 28, 2022

Public Version Number

7

DI Record Publish Date

January 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-