Catalog Number

-

Brand Name

CX50N

Version/Model Number

CX50YQS

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

K170783

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Public Device Record Key

f891fd2b-67ac-4347-9305-5027c0b29b6f

Public Version Date

October 24, 2022

Public Version Number

5

DI Record Publish Date

April 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-