Home GUDID 10884521703209 Emprint SX
Primary DI 10884521703209
Brand Emprint SX
Company Covidien LP
Model CASYS100
Device description Ablation Platform with Thermosphere Technology
Published 2017-12-13
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GEI Electrosurgical, cutting & coagulation & accessories NEY SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2 NEY System, Ablation, Microwave And Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10884521703209 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10884521703209 10884521703209
GMDN Terms# Term, Definition table Term Definition Microwave ablation system generator A mains electricity (AC-powered) device intended to generate microwave energy for localized non-vascular soft-tissue ablation, typically to treat tumours and/or hydatid cysts. The generator connects via a delivery cable to a probe (not included) for delivery of microwaves to the target tissues. It is intended to be used in percutaneous, laparoscopic, or open surgery procedures to ablate tissue typically in the liver, lung, pancreas and kidney.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Handling Environment Atmospheric Pressure 66 KiloPascal 1060 KiloPascal Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Humidity 20 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature -10 Degrees Celsius 50 Degrees Celsius Handling Environment Temperature 10 Degrees Celsius 50 Degrees Celsius Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Humidity 30 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 90 Degrees Celsius Storage Environment Temperature 10 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 058614483 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# 
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