Catalog Number

EMRT-8331

Brand Name

BIONIX RADIATION THERAPY

Version/Model Number

EMRT-8331

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

7832df1d-04f2-42a1-a7ff-d0bc17be511e

Public Version Date

March 26, 2021

Public Version Number

4

DI Record Publish Date

October 10, 2017

Package DI Number

10817740021045

Quantity per Package

5

Contains DI Package

00817740021048

Package Discontinue Date

October 30, 2020

Package Status

Not in Commercial Distribution

Package Type

box