Home GUDID 07540270000032
Occlusin 500
Primary DI 07540270000032
Brand Occlusin 500
Company IMBiotechnologies Ltd
Model Ekobi 503
Device description Occlusin 500 is a family of biodegradable, dense, hyperechoic microspheres, which are available in a range of calibrated sizes and marketed under the trade name Ekobi Embolization Microspheres. The microspheres consist of poly-DL-lactic-co-glycolic acid (PLGA) coated with bovine collagen. Following injection into the target vasculature, the collagen binds circulating platelets resulting in a platelet-rich clot which occludes the target vasculature. The microspheres slowly degrade and are removed from the body over 4-6 months.
Published 2019-05-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 07540270000032 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07540270000032 07540270000032 7540270000032
GMDN Terms# Term, Definition table Term Definition Embolization particle, bioabsorbable A sterile, bioabsorbable, implantable bead/microsphere intended to be used to temporarily occlude an artery supplying hyperplastic/neoplastic tissue in a variety of anatomies (e.g., liver, lung, breast, bladder, uterus, head or neck); it does not include a pharmaceutical agent. It may be used independently to create ischemia in the tissue, or as an adjuvant in combination with cytostatic agents and other antitumour drugs to help optimize intra-tumour drug accumulation for interventional radiology and visceral surgery procedures. It is typically available as an injectable solution containing numerous microspheres [e.g., degradable starch microspheres (DSM)]. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in cool, dry location
Regulatory Flags# DUNS number 244234295 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 07613327635096 InZone IST Stryker Corporation KRD 2026-07-08 00840303714521 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714538 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714545 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714552 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714569 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714576 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714583 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714590 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714606 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714613 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714620 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714637 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714644 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714651 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714668 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714675 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714682 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00840303714699 Optima Coil System (OptiOne Coil System) BALT USA LLC KRD 2026-07-06 00763000495626 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. KRD 2023-08-07 00763000495633 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. KRD 2023-08-07 00763000495657 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. KRD 2023-08-07 00763000495664 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. KRD 2023-08-07 00763000488000 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488017 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488024 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488031 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488147 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488154 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488192 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28