Catalog Number

ERB-90-SS

Brand Name

BIONIX RADIATION THERAPY

Version/Model Number

ERB-90-SS

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

PCT

Product Code Name

Prostate immobilizer rectal balloon

Public Device Record Key

43f26c0f-9503-4a61-823d-9b1193bb9e82

Public Version Date

January 13, 2021

Public Version Number

3

DI Record Publish Date

April 25, 2017

Package DI Number

10817740021007

Quantity per Package

12

Contains DI Package

00817740021000

Package Discontinue Date

August 30, 2019

Package Status

Not in Commercial Distribution

Package Type

box