REFERENCE DETECTOR (BNC) 10460000Z

GUDID B01610460000Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe

• Primary Device ID: B01610460000Z0
• NIH Device Record Key: 0d22b004-b679-40e4-9ded-d091b77db15c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REFERENCE DETECTOR (BNC)
• Version Model Number: 10460000Z
• Catalog Number: 10460000Z
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
• Handling Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Special Storage Condition, Specify: Between 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
• Handling Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B01610460000Z0 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-06

On-Brand Devices [REFERENCE DETECTOR (BNC)]

• B01610460000Z0: Radiation therapy QA device.
• 05060608880287: Radiation therapy QA device.