IC PROFILER

Primary DI
05060608880751
Brand
IC PROFILER
Company
SUN NUCLEAR CORP.
Model
1122800Z
Catalog number
1122000-0Z
Device description
Radiation therapy QA device.
Published
2020-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LHOInstrument, Quality-Assurance, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060608880751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608880751050606088807515060608880751

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system quality assurance deviceAn instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00CAUTION: Do not store IC PROFILER in the treatment room where the electronics can be accidentally irradiated by the direct beam.
Special Storage Condition, Specify00If the storage location does not provide ideal conditions, protect the device by sealing it in a moisture barrier bag with desiccant
Special Storage Condition, Specify00Never store device where it can accidentally be irradiated, such as a shelf in the treatment room that is irradiated by the beam when the linac is rotated
Special Storage Condition, Specify00Store the device in an indoor, climate-controlled environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
Special Storage Condition, Specify00Store the instrument in an indoor, protected environment where the instrument will not be irradiated by the direct beam
Special Storage Condition, Specify00When storing or transporting the IC PROFILER Model 1122, precautions must be taken to protect the device from shock, vibration, moisture, and atmospheric changes
Special Storage Condition, Specify00Whether storing or shipping the IC PROFILER, follow the packing instructions to minimize the environmental effects and to protect the device from physical damage
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
122240021
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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