Catalog Number

K9301628B

Brand Name

Coronis Fusion 4MP

Version/Model Number

MDCC-4430

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

K191845

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Public Device Record Key

2bfad039-de04-4f47-969c-8644ad8e347d

Public Version Date

May 25, 2022

Public Version Number

1

DI Record Publish Date

May 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-