C339 V

Basic Information

• Brand Name: C339 V
• Primary DI: 08059307491419
• Version / Model: C339 V
• Company Name: I.A.E. INDUSTRIA APPLICAZIONI ELETTRONICHE SPA
• Labeler DUNS: 430263475
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-25
• Public Version: 1
• Public Version Date: 2020-09-02
• Public Version Status: New
• Public Device Record Key: ab80da20-f427-4078-9f9f-d131a4102528

Device Description

Rotating anode X-ray tube unit for radiography systems

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: Yes
• 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
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	892.1760	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36593	X-ray system tube rotating anode assembly	A component of an x-ray tube, the rotating anode subassembly provides the means to rotate a disc made of tungsten (W) or an alloy of tungsten at speeds above 3000 revolutions per minute while the x-ray tube is operational. The disc is contained within the vacuum of the glass x-ray tube. The power to effect rotation is provided by a magnetic field produced by stator coils which surround the neck of the x-ray tube outside the glass envelope. This mechanism is used in x-ray tube designs in order to dissipate the heat generated by x-ray tubes and to allow them to withstand the heat generated by large x-ray exposures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08059307491419	GS1