Catalog Number

9806-058-01351

Brand Name

XS-100 X-Ray Tube Assembly

Version/Model Number

9806-058-01351

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

ITY

Product Code Name

Assembly, tube housing, x-ray, diagnostic

Public Device Record Key

8741a72b-ba7a-42d4-86c1-385b6831f148

Public Version Date

August 02, 2021

Public Version Number

1

DI Record Publish Date

July 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-