Avanza

Basic Information

• Brand Name: Avanza
• Primary DI: 07540146000050
• Version / Model: Avanza
• Company Name: Best Theratronics Ltd
• Labeler DUNS: 243606832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 4
• Public Version Date: 2020-01-20
• Public Version Status: Update
• Public Device Record Key: 52567c14-4257-4927-bdcf-9fe559473779

Device Description

Patient positioning table

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
JAI	Couch, Radiation Therapy, Powered	Radiology	892.5770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40685	Teletherapy radionuclide system table, powered	A device that is a component of a teletherapy radionuclide system (commonly known as a cobalt therapy machine) and that is a powered/programmable table specifically designed to position and support a patient during treatments administered using a therapeutic radionuclide teletherapy system (e.g., a Cobalt-60 teletherapy system). It has electronic and/or software controls for table top height and positioning. It can be a stationary or mobile unit, or incorporated as an integral component of a radionuclide teletherapy system or gantry configuration.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540146000050	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060870	000