AccessGUDID - DEVICE: BIONIX RADIATION THERAPY (08177400245002)

GUDID

Device Identifier (DI) Information

Brand Name: BIONIX RADIATION THERAPY
Version or Model: SBRT-4500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SBRT-4500
Company Name: Bionix Radiation Therapy, LLC

Primary DI Number: 08177400245002
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 080397923 *Terms of Use

Device Description: OMNI V SBRT POSITIONING SYSTEM

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:	No
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?
61110	Radiation therapy treatment planning positioning kit	A collection of non-sterile devices intended to assist collection of diagnostic magnetic resonance imaging (MRI) images to be used as part of radiation therapy treatment planning. It includes multiple devices intended to ensure adequate positioning and/or immobilization of the patient during MRI imaging (e.g., radiological whole-body positioning frame/board, laser patient positioning system), and may include imaging supportive/reference devices (e.g., MRI phantom).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, linear, medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100691	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f20e5897-63aa-467a-b792-654005a4378d
Public Version Date: July 10, 2023
Public Version Number: 4
DI Record Publish Date: October 27, 2016