REFERENCE DETECTOR (TNC) 1046000-1Z

GUDID 05060608880294

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 Solid-state-semiconductor radiation measuring probe Solid-state-semiconductor radiation measuring probe
Primary Device ID05060608880294
NIH Device Record Key223dceaf-34f3-4525-bbb5-0cb36f1d0298
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFERENCE DETECTOR (TNC)
Version Model Number1046400Z
Catalog Number1046000-1Z
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal
Special Storage Condition, SpecifyBetween 0 and 0 *Do not allow water near the chamber body seam or the connector end, and do not allow any liquid to flow into the connector cavity.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid getting the inside of the connector dirty or measurements may suffer.
Special Storage Condition, SpecifyBetween 0 and 0 *Long exposure to high humidity may have an adverse effect on measurements. If the device has been exposed to high humidity and exhibits abnormal leakage results, place in a cool and dry environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the Reference Detector and cable in the storage case in an indoor, protected environment.
Special Storage Condition, SpecifyBetween 0 and 0 *Clean the Reference Detector by wiping with a clean dry cloth, which may be slightly moistened with alcohol.
Storage Environment Atmospheric PressureBetween 57.2 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
GS105060608880294 [Primary]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]
HIBCCB01610460001Z0 [Previous]

FDA Product Code

LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic
LHOInstrument, Quality-Assurance, Radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [REFERENCE DETECTOR (TNC)]

B01610460001Z0Radiation therapy QA device.
05060608880294Radiation therapy QA device.

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