Catalog Number

-

Brand Name

ClearRead Detect Docker

Version/Model Number

1.2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

de478d01-b250-4096-b4eb-0a932ea55e8c

Public Version Date

May 11, 2022

Public Version Number

2

DI Record Publish Date

October 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-