Home GUDID 00850042341018 Easi-Vue embolic microspheres System
Primary DI 00850042341018
Brand Easi-Vue embolic microspheres System
Company ABK Biomedical Incorporated
Model Administration Kit 50 micron
Catalog number EVA50
Published 2022-10-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name KRD Device, Vascular, For Promoting Embolization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRD Device, Vascular, For Promoting Embolization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850042341018 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850042341018 00850042341018 850042341018 0850042341018
GMDN Terms# Term, Definition table Term Definition Embolization particle, non-bioabsorbable A non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 16 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 203463617 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00850042341025 Easi-Vue embolic microspheres System Administration Kit 100 micron EVA100 2022-10-24 00850042341032 Easi-Vue embolic microspheres System Administration Kit 150 micron EVA150 2022-10-24 00850042341094 Easi-Vue embolic microspheres System EVD100 2024-03-12 00850042341100 Easi-Vue embolic microspheres System EVD150 2024-03-12 00850042341087 Easi-Vue embolic microspheres System EVD50 2024-03-12 10850042341091 Easi-Vue embolic microspheres System EVD100 2024-03-12 10850042341107 Easi-Vue embolic microspheres System EVD150 2024-03-12 00850042341049 Easi-Vue embolic microspheres System Refill Syringe 50 micron EVR50 2022-10-24 00850042341056 Easi-Vue embolic microspheres System Refill Syringe 100 micron EVR100 2022-10-24 00850042341063 Easi-Vue embolic microspheres System Refill Syringe 150 micron EVR150 2022-10-24 10850042341046 Easi-Vue embolic microspheres System Refill Syringe 50 micron EVR50 2022-10-24 10850042341053 Easi-Vue embolic microspheres System Refill Syringe 100 micron EVR100 2022-10-24 10850042341060 Easi-Vue embolic microspheres System Refill Syringe 150 micron EVR150 2022-10-24
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