Catalog Number

-

Brand Name

Xplorer 1590 Digital Radiographic System

Version/Model Number

1590 X4C

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

-

Product Code

KPR

Product Code Name

System, x-ray, stationary

Public Device Record Key

acf48776-f3d0-448d-9d8b-2404aa1f2e57

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-