Catalog Number

-

Brand Name

ArtPiX Mobile EZ2GO

Version/Model Number

62833765

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162224

Product Code

KPR

Product Code Name

System, X-Ray, Stationary

Public Device Record Key

a9280d4f-5f3f-4881-9667-bce559c85944

Public Version Date

March 03, 2021

Public Version Number

2

DI Record Publish Date

September 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-