SNC350p (TNC) 10450001Z

GUDID B01610450001Z0

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe

• Primary Device ID: B01610450001Z0
• NIH Device Record Key: 6e7c5686-a410-43fb-b8aa-65891ed79b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SNC350p (TNC)
• Version Model Number: 10450001Z
• Catalog Number: 10450001Z
• Company DUNS: 122240021
• Company Name: SUN NUCLEAR CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
• Special Storage Condition, Specify: Between 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
• Special Storage Condition, Specify: Between 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.
• Storage Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 18.7 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *Dry the chamber, cable, connector and detector holders thoroughly before placing in storage case.
• Special Storage Condition, Specify: Between 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If chamber has been exposed to high humidity and exhibits abnormal leakage results, place chamber in a cool and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *If abnormal behavior continues the chamber can be placed at an elevated temperature with lower humidity. Do not use for measurements while the chamber is exhibiting abnormal behavior.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SNC350p/accessories in the storage case, in an indoor, protected environment where they will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Store the SNC350p and accessories in the appropriate foam cutouts. To avoid damage to the SNC350p chamber, do not store buildup caps or other accessories loose in the storage case.
• Special Storage Condition, Specify: Between 0 and 0 *The storage case supplied with the SNC350p is designed for hand transport. For shipping, the storage case should always be packed in a secondary shipping container designed for fragile objects.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B01610450001Z0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112981

FDA Product Code

• LHN: System, Radiation Therapy, Charged-Particle, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-14

On-Brand Devices [SNC350p (TNC)]

• B01610450001Z0: Radiation therapy QA device.
• 05060608880232: Radiation therapy QA device.