Home GUDID 08714729944003 Embozene®
Primary DI 08714729944003
Brand Embozene®
Company BOSTON SCIENTIFIC CORPORATION
Model 01-0301-13002-11
Device description Microspheres for Embolization
Published 2016-06-06
Public version status Update
Distribution status 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 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 08714729944003 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08714729944003 08714729944003 8714729944003
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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0
Regulatory Flags# DUNS number 021717889 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# 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