Home GUDID 10884450123345 Bearing nsPVA®
Primary DI 10884450123345
Brand Bearing nsPVA®
Company Merit Medical Systems, Inc.
Model 00884450123348
Catalog number V400EP
Published 2015-10-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NAJ AGENTS,EMBOLIC,FOR TREATMENT OF UTERINE FIBROIDS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NAJ Agents, Embolic, For Treatment Of Uterine Fibroids Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10884450123345 Package GS1 5 In Commercial Distribution 00884450123348 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 10884450123345 10884450123345 00884450123348 00884450123348 884450123348 0884450123348
GMDN Terms# Term, Definition table Term Definition Embolization particle, non-bioabsorbable A sterile, 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
Regulatory Flags# DUNS number 184763290 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 00810563021080 Embozene Color Advance 100um Embozene 2mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021097 Embozene Color Advance 250um Embozene 2mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021110 Embozene Color Advance 500um Embozene 2mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021424 ONCOZENE 40um Oncozene 2mL - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021455 ONCOZENE 75um Oncozene 3mL - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021509 Embozene Color Advance 100um Embozene 1mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021516 Embozene Color Advance 250um Embozene 1mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021547 Embozene Color Advance 700um Embozene 1mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021554 Embozene Color Advance 900um Embozene 1mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021561 Embozene Color Advance 1100um Embozene 1mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 00810563021578 Embozene Color Advance 1300um Embozene 1mL Colored - US VARIAN MEDICAL SYSTEMS, INC. NAJ 2023-05-19 10884450299439 Embosphere® BIOSPHERE MEDICAL NAJ 2022-09-20 00191506011369 Bead Block™ BOSTON SCIENTIFIC CORPORATION NAJ 2021-10-14 00812636020662 HydroPearl MICROVENTION INC. NAJ 2020-05-14 00812636020624 HydroPearl MICROVENTION INC. NAJ 2018-11-22 00812636020655 HydroPearl MICROVENTION INC. NAJ 2018-11-22 00816777026088 HydroPearl MICROVENTION INC. NAJ 2018-08-07 00816777026095 HydroPearl MICROVENTION INC. NAJ 2018-08-07 00816777026101 HydroPearl MICROVENTION INC. NAJ 2018-08-07 00816777026118 HydroPearl MICROVENTION INC. NAJ 2018-08-07 00816777026125 HydroPearl MICROVENTION INC. NAJ 2018-08-07 00816777026132 HydroPearl MICROVENTION INC. NAJ 2018-08-07 00812636020617 HydroPearl MICROVENTION INC. NAJ 2018-08-07 00812636020631 HydroPearl MICROVENTION INC. NAJ 2018-08-07 00812636020648 HydroPearl MICROVENTION INC. NAJ 2018-08-07 10884450089238 Embosphere® BIOSPHERE MEDICAL NAJ 2016-09-24 10884450089252 Embosphere® BIOSPHERE MEDICAL NAJ 2016-09-24 10884450089276 Embosphere® BIOSPHERE MEDICAL NAJ 2016-09-24 10884450089337 Embosphere® BIOSPHERE MEDICAL NAJ 2016-09-24 10884450089290 Embosphere® BIOSPHERE MEDICAL NAJ 2016-09-20