Catalog Number

BKRT-5036

Brand Name

BIONIX RADIATION THERAPY

Version/Model Number

BKRT-5036

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

Yes

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

c902ccd7-98f2-4ea0-bc90-8d4765385e3f

Public Version Date

March 29, 2021

Public Version Number

6

DI Record Publish Date

April 25, 2017

Package DI Number

10817740020031

Quantity per Package

10

Contains DI Package

00817740020034

Package Discontinue Date

October 30, 2020

Package Status

Not in Commercial Distribution

Package Type

box