Catalog Number

MXU-RV19

Brand Name

Micro-X

Version/Model Number

Rover

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

K211423

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Public Device Record Key

21c9135e-acca-475e-90a7-7d3e962a65e2

Public Version Date

June 28, 2021

Public Version Number

1

DI Record Publish Date

June 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-