BIONIX RADIATION THERAPY

Basic Information

• Brand Name: BIONIX RADIATION THERAPY
• Primary DI: 00817740020201
• Version / Model: EMRT-8330
• Catalog Number: EMRT-8330
• Company Name: Bionix Radiation Therapy, LLC
• Labeler DUNS: 080397923
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-25
• Public Version: 5
• Public Version Date: 2023-07-10
• Public Version Status: Update
• Public Device Record Key: d1b7236b-e6be-4d7f-9cf8-3da65a1e15d4
• Distribution End Date: 2020-10-30

Device Description

2.4MM HEAD ONLY SECUREFRAME

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYE	Accelerator, linear, medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58757	Spine thermoplastic splint system	An assembly of non-sterile devices designed to produce a thermoformable splint intended to be applied externally to the spine of a patient who requires support or immobilization (e.g., to treat fractures, injuries, sprains). It typically consists of a low-temperature thermoplastic material and a textile (e.g., cotton) in the form of the spine and into which the thermoplastic is inserted; the combination is warmed in a water bath for adaptability to the shape of the patient?s spine. It is available in various dimensions and may be used in various clinical specialties. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817740020208	GS1	box	6	Not in Commercial Distribution	2020-10-30
Primary	00817740020201	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]