Catalog Number

SBRT-4500

Brand Name

BIONIX RADIATION THERAPY

Version/Model Number

SBRT-4500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2017

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

K100691

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

f20e5897-63aa-467a-b792-654005a4378d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-