REFERENCE DETECTOR (TNC)

Basic Information

• Brand Name: REFERENCE DETECTOR (TNC)
• Primary DI: 05060608880294
• Version / Model: 1046400Z
• Catalog Number: 1046000-1Z
• Company Name: SUN NUCLEAR CORP.
• Labeler DUNS: 122240021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-22
• Public Version: 1
• Public Version Date: 2020-07-30
• Public Version Status: New
• Public Device Record Key: 223dceaf-34f3-4525-bbb5-0cb36f1d0298

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: Yes
• 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
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	892.1940	1

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	05060608880294	GS1
Previous	B01610460001Z0	HIBCC

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 35 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 57.2 – 106 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid getting the inside of the connector dirty or measurements may suffer.
• Type: Special Storage Condition, Specify
• Special Conditions: Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
• Type: Special Storage Condition, Specify
• Special Conditions: Store the Reference Detector and cable in the storage case in an indoor, protected environment.
• Type: Special Storage Condition, Specify
• Special Conditions: Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57.2 – 106 KiloPascal