SRS MapCHECK 1179000-0Z

GUDID 05060608880188

Radiation therapy 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 ID05060608880188
NIH Device Record Keyec1b0272-b579-49fa-abcd-cda48e803036
Commercial Distribution StatusIn Commercial Distribution
Brand NameSRS MapCHECK
Version Model Number1179300Z
Catalog Number1179000-0Z
Company DUNS122240021
Company NameSUN NUCLEAR CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store the instrument in the treatment room.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the SRS MapCHECK, ancillary parts, and accessories in an indoor, protected environment.
Handling Environment TemperatureBetween -30 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Choose a storage location where the instrument will not be irradiated by the direct beam and where scattered radiation will be kept at a minimum.

Device Identifiers

Device Issuing AgencyDevice ID
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
GS105060608880188 [Primary]
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HIBCCB01611790000Z0 [Previous]
HIBCCB01611790000Z0 [Previous]
HIBCCB01611790000Z0 [Previous]
HIBCCB01611790000Z0 [Previous]
HIBCCB01611790000Z0 [Previous]
HIBCCB01611790000Z0 [Previous]
HIBCCB01611790000Z0 [Previous]
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FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical
IYEAccelerator, Linear, Medical

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 [SRS MapCHECK]

B01611790000Z0Radiation therapy QA device.
05060608880188Radiation therapy QA device.

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