rf-IVD 2

Basic Information

• Brand Name: rf-IVD 2
• Primary DI: 05060608880041
• Version / Model: 1136000-0Z
• Catalog Number: 1136000-0Z
• Company Name: SUN NUCLEAR CORP.
• Labeler DUNS: 122240021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-24
• Public Version: 1
• Public Version Date: 2020-08-03
• Public Version Status: New
• Public Device Record Key: aae96211-b145-4b98-90e7-a8de9f2719cb

Device Description

Radiation therapy QA device.

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
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38336	Solid-state-semiconductor radiation measuring probe	A device covering a variety of radiation detector probe designs incorporating a solid-state semiconductor serving as an ionization chamber. It is used as a component of a survey meter or analytical instrument used for radiation detection and measurement. It is typically used to detect low amounts of radioactivity and its energy discrimination properties allow it to be incorporated in radiation detection, measurement instruments and radiation spectroscopy systems. The composition and impurities in the semiconductor material used determine its energy discrimination capabilities and the kind of radiation (x-ray, gamma ray, high-energy beta particles or neutrons) that can be detected.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060608880041	GS1
Previous	B01611360000Z0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K011332	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store the IVD system components in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation is kept at a minimum.