SunSILICON

Basic Information

• Brand Name: SunSILICON
• Primary DI: 05060608881192
• Version / Model: 1048
• Company Name: SUN NUCLEAR CORP.
• Labeler DUNS: 122240021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-08
• Public Version: 1
• Public Version Date: 2025-07-16
• Public Version Status: New
• Public Device Record Key: 75e77c91-96d8-4d5f-94be-c35fe8895c0e

Device Description

The SunSILICON detector is intended for use as a relative dosimetry detector in measurements of ionizing radiation emitted from a treatment delivery 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: MR Conditional
• 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
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	05060608881192	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K051921	000