Catalog Number

-

Brand Name

ClearRead +Confirm

Version/Model Number

2.1.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2016

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

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

448f2c76-288a-4347-ac52-038e0993b9e0

Public Version Date

May 11, 2022

Public Version Number

5

DI Record Publish Date

September 25, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-