rf-IVD 2 1136000-0Z

GUDID 05060608880041

Radiation therapy QA device.

SUN NUCLEAR CORP.

Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe

• Primary Device ID: 05060608880041
• NIH Device Record Key: aae96211-b145-4b98-90e7-a8de9f2719cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: rf-IVD 2
• Version Model Number: 1136000-0Z
• Catalog Number: 1136000-0Z
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880041 [Primary]
HIBCC	B01611360000Z0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011332

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-03
• Device Publish Date: 2020-07-24

On-Brand Devices [rf-IVD 2]

• B01611360000Z0: Radiation therapy QA device.
• 05060608880041: Radiation therapy QA device.