Home GUDID 17290019747038 Neurolyser XR DQA Assembly
Primary DI 17290019747038
Brand Neurolyser XR DQA Assembly
Company FUSMobile LTD
Model 820-00008
Published 2025-12-10
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name SGN High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SGN High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17290019747038 Package GS1 1 In Commercial Distribution 07290019747031 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17290019747038 17290019747038 07290019747031 07290019747031 7290019747031
GMDN Terms# Term, Definition table Term Definition Fluoroscopic x-ray phantom, test object A device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of fluoroscopic x-ray systems and associated image display systems, image acquisition software, and related system and application software programs.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Don't expose to sunlight Storage Environment Temperature -10 Degrees Celsius 27 Degrees Celsius
Regulatory Flags# DUNS number 531885190 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290019747031 Neurolyser XR DQA Assembly 820-00008 2025-12-10 07290019747000 Neurolyser XR NXR100 2025-12-10 07290019747017 Neurolyser XR 30 mm Gel Pad 415-00002 2025-12-10 07290019747024 Neurolyser XR 45 mm Gel Pad 415-00003 2025-12-10
Other Devices Sharing Product Codes#