FDA.reportPublic FDA data

SRS PROFILER

Primary DI
05060608880089
Brand
SRS PROFILER
Company
SUN NUCLEAR CORP.
Model
1202500Z
Catalog number
1202000-0Z
Device description
Radiotherapeutic quality assurance instrument
Published
2019-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05060608880089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060608880089050606088800895060608880089

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, Specify00Do not store the SRS PROFILER where the electronics can be accidentally irradiated by the direct beam
Special Storage Condition, Specify00Never leave the instrument on the treatment couch during warm-up.
Special Storage Condition, Specify00Never store the instrument where it can accidentally be irradiated, such as the wall mount accessory or a shelf in the treatment room that may be irradiated by the beam when the accelerator is rotated
Special Storage Condition, Specify00Store the instrument in an indoor, protected environment where it will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, Specify00Store the SRS PROFILER in a location where it will not be exposed to direct radiation or heavy scattering, which can damage the electronics.
Special Storage Condition, Specify00Store the SRS PROFILER in an indoor, protected environment where it will not be irradiated by the direct beam and where scatter radiation will be kept to a minimum.
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 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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Primary DI, Brand, Company table
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