Home GUDID 00840303714293
Optima Coil System (OptiOne Coil System)
Primary DI 00840303714293
Brand Optima Coil System (OptiOne Coil System)
Company BALT USA LLC
Model OPTIONE35M
Catalog number N/A
Device description The Optima Coil System is a series of specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum and tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths, and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are detached from the delivery pusher in a serial manner until the aneurysm is occluded.
Published 2026-01-28
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
Sterile true
Single use true
Product Codes# Code, Name table Code Name HCG Device, Neurovascular Embolization KRD Device, Vascular, For Promoting Embolization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HCG Device, Neurovascular Embolization Neurology 2 KRD Device, Vascular, For Promoting Embolization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840303714293 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 00840303714293 00840303714293 840303714293 0840303714293
GMDN Terms# Term, Definition table Term Definition Neurovascular embolization coil A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
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 at a controlled room temperature in a dry place.
Regulatory Flags# DUNS number 945543689 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840303714255 Optima Coil System (OptiOne Coil System) OPTIONE3S N/A 2026-01-28 00840303714262 Optima Coil System (OptiOne Coil System) OPTIONE3M N/A 2026-01-28 00840303714279 Optima Coil System (OptiOne Coil System) OPTIONE3L N/A 2026-01-28 00840303714286 Optima Coil System (OptiOne Coil System) OPTIONE35S N/A 2026-01-28 00840303714309 Optima Coil System (OptiOne Coil System) OPTIONE35L N/A 2026-01-28 00840303714316 Optima Coil System (OptiOne Coil System) OPTIONE4S N/A 2026-01-28 00840303714323 Optima Coil System (OptiOne Coil System) OPTIONE4M N/A 2026-01-28 00840303714330 Optima Coil System (OptiOne Coil System) OPTIONE4L N/A 2026-01-28 00840303714347 Optima Coil System (OptiOne Coil System) OPTIONE45S N/A 2026-01-28 00840303714354 Optima Coil System (OptiOne Coil System) OPTIONE45M N/A 2026-01-28 00840303714361 Optima Coil System (OptiOne Coil System) OPTIONE45L N/A 2026-01-28 00840303714378 Optima Coil System (OptiOne Coil System) OPTIONE5S N/A 2026-01-28 00840303714385 Optima Coil System (OptiOne Coil System) OPTIONE5M N/A 2026-01-28 00840303714392 Optima Coil System (OptiOne Coil System) OPTIONE5L N/A 2026-01-28 00840303714408 Optima Coil System (OptiOne Coil System) OPTIONE5XL N/A 2026-01-28 00840303714415 Optima Coil System (OptiOne Coil System) OPTIONE55S N/A 2026-01-28 00840303714422 Optima Coil System (OptiOne Coil System) OPTIONE55M N/A 2026-01-28 00840303714439 Optima Coil System (OptiOne Coil System) OPTIONE55L N/A 2026-01-28 00840303714446 Optima Coil System (OptiOne Coil System) OPTIONE55XL N/A 2026-01-28 00840303714453 Optima Coil System (OptiOne Coil System) OPTIONE6S N/A 2026-01-28
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000495626 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. HCG 2023-08-07 00763000495626 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. KRD 2023-08-07 00763000495633 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. HCG 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 00763000495657 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. HCG 2023-08-07 00763000495664 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. HCG 2023-08-07 00763000495664 Axium™ Prime Detachable Coil System Micro Therapeutics, Inc. KRD 2023-08-07 00763000488000 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488000 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488024 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488024 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488031 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488031 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488147 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488147 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488154 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488154 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488178 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488208 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488208 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488215 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488215 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488222 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488222 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488246 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488246 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488253 Axium™ Detachable Coil System Micro Therapeutics, Inc. KRD 2022-10-28 00763000488253 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28 00763000488277 Axium™ Detachable Coil System Micro Therapeutics, Inc. HCG 2022-10-28