Home GUDID 00810563021097 Embozene Color Advance 250um Embozene 2mL Colored - US
Primary DI 00810563021097
Brand Embozene Color Advance 250um Embozene 2mL Colored - US
Company Varian Medical Systems, Inc.
Model 12020-S1
Published 2023-05-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Sterile true
Single use true Product Codes# Code, Name table Code Name KRD Device, Vascular, for Promoting Embolization NAJ Agents, embolic, for treatment of uterine fibroids NOY Agents, embolic, for treatment of benign prostatic hyperplasia
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRD Device, Vascular, For Promoting Embolization Cardiovascular 2 NAJ Agents, Embolic, For Treatment Of Uterine Fibroids Cardiovascular 2 NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810563021097 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 00810563021097 00810563021097 810563021097 0810563021097
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.
Regulatory Flags# DUNS number 118097024 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10816389027296 Universal fixation button, radiopaque, pack of 100, non-sterile GM11003800 GM11003800 2016-09-23 00810563021967 Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin GM11014710 GM11014710 2024-02-16 00810563021974 Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin GM11014720 GM11014720 2024-02-16 00810563021981 Plastic needle MR safe, 2.0 mm diameter x 320 mm length, blunt tip, with mandrin GM11014730 GM11014730 2024-02-16 00810563022001 Mandrin for 200 mm length GM11010450 GM11010450 2024-02-16 00810563022018 Mandrin for 320 mm length GM11010470 GM11010470 2024-02-16 00810563022025 Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin GM11014700 GM11014700 2024-02-16 00810563021998 Mandrin for 113 mm length GM11010390 GM11010390 2024-02-16 00816389022522 Mandrin for 200mm length Needle for Plastic Interstitial Needle GM11003270 GM11003270 2021-02-02 00816389022188 Flexible probe, 2.8 mm diameter x 320 mm GM11002280 GM11002280 2016-09-22 00816389022195 Mould probe, ø 1.8 diameter x 320 mm, with mandrin GM11002290 GM11002290 2016-09-19 00816389022478 Mandrin for 320mm length GM11003100 GM11003100 2016-09-23 00816389022553 Mandrin for 113mm length Needle GM11003340 GM11003340 2016-09-22 00816389022935 Catheter flap 200 mm x 290 mm x 10 mm, 40 channels GM11003910 GM11003910 2016-09-23 00816389024243 Plastic needle, 2.0 mm diameter, 113 mm length with mandrin for 113 mm needles GM11007560 GM11007560 2016-09-22 00816389024250 Plastic needle 2.0 mm diameter, 200 mm length with mandrin for 200 mm needles GM11007570 GM11007570 2016-09-18 00816389024267 Plastic needle ø 2.0 mm diameter, 320 mm length with mandrin for 320 mm needles GM11007580 GM11007580 2016-09-19 00816389025615 Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrin GM11010750 GM11010750 2016-09-22 00854393006084 Velocity 4.3 Velocity 4.3 2026-07-16 10816389027234 Cleaning Cap, dark blue (pack of 25) GM11010770 GM11010770 2016-09-22
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10886704080121 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080138 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080145 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080152 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080206 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704080213 GALAXY G3 Cerenovus, Inc. KRD 2017-11-03 10886704076957 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076971 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076988 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077022 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077039 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077046 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077077 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077176 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077183 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077299 DELTAXSFT Cerenovus, Inc. KRD 2016-11-16 10886704077374 DELTAXSFT Cerenovus, Inc. KRD 2016-11-16 10886704076933 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704076940 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077091 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077114 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077121 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077138 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077145 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077152 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077169 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077190 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077213 MICRUSFRAME Cerenovus, Inc. KRD 2016-11-16 10886704077220 DELTAFILL Cerenovus, Inc. KRD 2016-11-16 10886704077237 DELTAFILL Cerenovus, Inc. KRD 2016-11-16