Catalog Number

-

Brand Name

RayStation

Version/Model Number

11B

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

MUJ

Product Code Name

System, Planning, Radiation Therapy Treatment

Public Device Record Key

4d5a2b9b-f3f2-49d5-82ab-b7d3b3bc96ee

Public Version Date

May 11, 2022

Public Version Number

1

DI Record Publish Date

May 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-