Catalog Number

6702336

Brand Name

Focus 43C Detector

Version/Model Number

Focus 43C Detector

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

MQB

Product Code Name

Solid state x-ray imager (flat panel/digital imager)

Public Device Record Key

7652b046-fff9-4489-ace5-73deccc9868e

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 26, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-