Home GUDID 04562122955850 HITACHI
Primary DI 04562122955850
Brand HITACHI
Company HITACHI, LTD.
Model UST-995-7.5
Device description Probe
Published 2016-09-13
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 Code Name ITX Transducer, Ultrasonic, Diagnostic IYN System, Imaging, Pulsed Doppler, Ultrasonic IYO System, Imaging, Pulsed Echo, Ultrasonic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2 IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology 2 IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04562122955850 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04562122955850 04562122955850 4562122955850
GMDN Terms# Term, Definition table Term Definition Surgical ultrasound imaging transducer A hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 75 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -10 Degrees Celsius 50 Degrees Celsius
Sterilization Methods# Method table Method "[""Liquid Chemical"", ""Peracetic Acid"", ""Hydrogen Peroxide"", ""Ethylene Oxide""]" Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
Regulatory Flags# DUNS number 693002605 Device count 1 Serial number true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes#