AccessGUDID - DEVICE: BIONIX RADIATION THERAPY (00817740020997)

GUDID

Device Identifier (DI) Information

Brand Name: BIONIX RADIATION THERAPY
Version or Model: E-APP-1-VS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: E-APP-1-VS
Company Name: Bionix Radiation Therapy, LLC

Primary DI Number: 00817740020997
Issuing Agency: GS1
Commercial Distribution End Date: October 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 080397923 *Terms of Use

Device Description: ESOPHAGEAL APPLICATOR

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38421	Oesophagus brachytherapy system applicator, remote-afterloading	A remote afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the oesophagus. It is designed for temporary implantation within the oesophageal region and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources. This GMDN code includes a variety of oesophageal applicators, e.g., hollow needles, tubes, or catheters, and their associated components.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAQ	System, applicator, radionuclide, remote-controlled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY ENVIRONMENT

Clinically Relevant Size

[?]

Size Type Text
Length: 11 Centimeter
Device Size Text, specify: BALLOON OUTER DIAMETER
Device Size Text, specify: TREATMENT LENGTH OF BALLOONS
Outer Diameter: 20 Millimeter

Device Record Status

Public Device Record Key: 680eff87-ce9d-4c29-bae4-b791514b4450
Public Version Date: July 10, 2023
Public Version Number: 4
DI Record Publish Date: April 25, 2017