NA

Basic Information

• Brand Name: NA
• Primary DI: 14987718300093
• Version / Model: AZ-733V
• Company Name: ANZAI MEDICAL CO., LTD.
• Labeler DUNS: 701259533
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 5739ea7f-3310-442e-8771-69985c02636b

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: Yes
• 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
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47928	Accelerator system synchronizer	A physiological monitoring unit used as a component of an accelerator system that produces a signal which enables the acceleration path of excited particles, usually electrons, and image formation or data collection to be synchronized with a specific measurable physiological parameter, e.g., the beginning of a patient's respiratory or cardiac cycle. It is primarily used as a trigger for accelerator system application and artifact reduction, or enhancement of signal-to-noise ratios in various real-time applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	14987718300093	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031385	000