TomoDose 1176000-0Z

GUDID 05060608880263

Radiotherapy quality assurance device

SUN NUCLEAR CORP.

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• Primary Device ID: 05060608880263
• NIH Device Record Key: eb218595-8907-4497-90dc-a0e174279a4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TomoDose
• Version Model Number: 1176300Z
• Catalog Number: 1176000-0Z
• 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

• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept to a minimum.
• Special Storage Condition, Specify: Between 0 and 0 *Never store the instrument where it can accidentally be irradiated, such as a shelf in the treatment room that may be irradiated by the beam when the gantry is rotated
• Special Storage Condition, Specify: Between 0 and 0 *Never leave the instrument on the treatment couch during warm-up.
• Special Storage Condition, Specify: Between 0 and 0 *Do not store the instrument where the electronics can be accidentally irradiated by the direct beam

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060608880263 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-30
• Device Publish Date: 2020-07-22

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