Catalog Number

-

Brand Name

Xstrahl 100 X-Ray System

Version/Model Number

Xstrahl 100 X-Ray System

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

-

Product Code

JAD

Product Code Name

System, Therapeutic, X-Ray

Public Device Record Key

3d9b249a-1517-4452-9e25-76113884f296

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-