Home GUDID 10850042341107 Easi-Vue embolic microspheres System
Primary DI 10850042341107
Brand Easi-Vue embolic microspheres System
Company ABK Biomedical Incorporated
Model EVD150
Published 2024-03-12
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
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 10850042341107 Package GS1 3 In Commercial Distribution 00850042341100 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 10850042341107 10850042341107 00850042341100 00850042341100 850042341100 0850042341100
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 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 true 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 00850042341018 Easi-Vue embolic microspheres System Administration Kit 50 micron EVA50 2022-10-24 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 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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