Catalog Number

UTRT-5010A

Brand Name

BIONIX RADIATION THERAPY

Version/Model Number

UTRT-5010A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 30, 2020

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

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

c1f3f1b2-1f60-4521-8f4e-f3750c0ac171

Public Version Date

March 26, 2021

Public Version Number

4

DI Record Publish Date

April 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-