StereoPHAN 1255000-0Z

GUDID 05060608880102

Radiation therapy, machine QA device

SUN NUCLEAR CORP.

Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device
Primary Device ID05060608880102
NIH Device Record Keyb596e112-9866-418b-9c22-58b90f039215
Commercial Distribution StatusIn Commercial Distribution
Brand NameStereoPHAN
Version Model Number1255300
Catalog Number1255000-0Z
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in an indoor, protected environment where scattered radiation will be kept at a minimum
Storage Environment Atmospheric PressureBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]
GS105060608880102 [Primary]

FDA Product Code

IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic
IXGPhantom, Anthropomorphic, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

Devices Manufactured by SUN NUCLEAR CORP.

05060608880041 - rf-IVD 22020-08-03 Radiation therapy QA device.
05060608880874 - PlanIQ2020-08-03 Radiation therapy QA software.
05060608880102 - StereoPHAN2020-07-31Radiation therapy, machine QA device
05060608880102 - StereoPHAN2020-07-31 Radiation therapy, machine QA device
05060608880751 - IC PROFILER2020-07-31 Radiation therapy QA device.
05060608880768 - IC PROFILER-MR2020-07-31 Radiation therapy QA device.
05060608880959 - Daily QA-MR2020-07-31 Radiation therapy QA device.
05060608880188 - SRS MapCHECK2020-07-30 Radiation therapy QA device.
05060608880232 - SNC350p (TNC)2020-07-30 Radiation therapy QA device.

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