Home GUDID 08714729942405 Embozene®
Primary DI 08714729942405
Brand Embozene®
Company BOSTON SCIENTIFIC CORPORATION
Model 01-0301-00752-11
Device description Microspheres for Embolization
Published 2016-06-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
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 08714729942405 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08714729942405 08714729942405 8714729942405
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 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 false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000936594 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936600 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936617 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936624 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936631 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936648 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936655 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936662 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936679 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936686 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936693 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936709 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936716 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936723 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936730 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936747 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936754 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936761 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936778 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936785 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936792 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936808 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936815 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936822 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936839 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936846 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936853 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936860 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936877 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27 00763000936884 Concerto Versa™ MEDTRONIC, INC. KRD 2026-02-27