Microblate Flex 7-AB1-001

GUDID 05060359560193

The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. 1.00 m long with a diameter of 2.00 mm

CREO MEDICAL LIMITED

Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered Microwave ablation system probe, non-powered
Primary Device ID05060359560193
NIH Device Record Key3200404d-50c1-4472-9161-093597e1d67f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroblate Flex
Version Model NumberAB1 Instrument
Catalog Number7-AB1-001
Company DUNS733853373
Company NameCREO MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+441291637300
Emailcustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com
Phone+18662261170
Emailuscustomerservice@creomedical.com

Device Dimensions

Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
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Outer Diameter2 Millimeter
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Outer Diameter2 Millimeter
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Outer Diameter2 Millimeter
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Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
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Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
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Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
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Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
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Length1 Meter
Outer Diameter2 Millimeter
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Length1 Meter
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Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter
Length1 Meter
Outer Diameter2 Millimeter

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric PressureBetween 69 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060359560193 [Package]
Contains: 05060359560209
Package: [5 Units]
In Commercial Distribution
GS105060359560209 [Primary]

FDA Product Code

NEYSystem, Ablation, Microwave And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-06
Device Publish Date2021-07-29

Devices Manufactured by CREO MEDICAL LIMITED

05060359560650 - Speedboat Ultraslim (SB1L) Electrosurgical Instrument2023-12-14 Speedboat UltraSlim is indicated for use in the cutting of soft tissue using radiofrequency current, the coagulation (haemostasi
05060359560599 - Speedboat RS2 8 Fr Instrument2023-11-16 A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosu
05060359560193 - Microblate Flex2021-08-06The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. 1.00 m long with a diameter of 2.00 mm
05060359560193 - Microblate Flex2021-08-06 The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of sof
05060359560292 - Croma2021-03-23 A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1)
05060359560223 - Croma2021-01-08 A flexible, invasive, hand-held endoscopic device assembly intended to deliver microwave energy to tissues for coagulation, whil
05060359560070 - Croma2020-12-01 A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and
05060359560025 - Creo Medical2020-02-06 A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosu
05060359560124 - Creo Medical2019-03-28 A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1)

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