Home GUDID 08720908310002 ARC-EX System
Primary DI 08720908310002
Brand ARC-EX System
Company ONWARD Medical N.V.
Model ARC-EX System - Professional US
Catalog number EXSYS01PROUS
Published 2024-12-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Physical Medicine 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08720908310040 Direct Marking GS1 0 08720908310002 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08720908310040 08720908310040 8720908310040 08720908310002 08720908310002 8720908310002
GMDN Terms# Term, Definition table Term Definition Spinal cord rehabilitation transcutaneous electrical stimulation system An electrically-powered device assembly intended to apply various modes of transcutaneous electrical stimulation to the spinal cord to improve or restore upper extremity sensory and motor function in adults with chronic neurological deficit resulting from incomplete spinal cord injury. It includes a portable electric current pulse generator and noninvasive electrodes. It is intended for use in the healthcare facility and in the home.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 0 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -13 Degrees Fahrenheit 158 Degrees Fahrenheit
Regulatory Flags# DUNS number 491823169 Device count 1 Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08720908310033 ARC-EX System ARC-EX System - Personal US EXSYS01PERUS 2025-12-05 08720908310040 ARC-EX System ARC-EX System - Professional US EXSYS01PROUS 2024-12-27
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08720908310033 ARC-EX System ONWARD Medical N.V. SDO 2025-12-05 08720908310040 ARC-EX System ONWARD Medical N.V. SDO 2024-12-27
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