Catalog Number

E-APP-1

Brand Name

BIONIX RADIATION THERAPY

Version/Model Number

E-APP-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 30, 2019

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

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

4510459c-cdb1-4489-a17c-b6ca4ee5e0fb

Public Version Date

January 13, 2021

Public Version Number

3

DI Record Publish Date

April 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-