Catalog Number

RT-4650

Brand Name

BIONIX RADIATION THERAPY

Version/Model Number

SBRT-4650

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 30, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

e627ee0e-c8b8-4d18-b91f-3f1d49ce4866

Public Version Date

November 25, 2020

Public Version Number

2

DI Record Publish Date

August 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-