Home GUDID 00840303713692
Optima Coil System
Primary DI 00840303713692
Brand Optima Coil System
Company BALT USA LLC
Model OPTIPAX1014
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 2025-10-02
Public version status New
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 00840303713692 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 00840303713692 00840303713692 840303713692 0840303713692
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 00840303712053 Prestige Coil System PRESPACK30 N/A 2026-07-14 00840303712077 Prestige Coil System PRESPACK65 N/A 2026-07-14 00840303712091 Prestige Coil System PRESPACK55 N/A 2026-07-14 00840303712107 Prestige Coil System PRESPACK55 N/A 2026-07-14 00840303714521 Optima Coil System (OptiOne Coil System) OPTIONE4S N/A 2026-07-06 00840303714538 Optima Coil System (OptiOne Coil System) OPTIONE4M N/A 2026-07-06 00840303714545 Optima Coil System (OptiOne Coil System) OPTIONE4L N/A 2026-07-06 00840303714552 Optima Coil System (OptiOne Coil System) OPTIONE45S N/A 2026-07-06 00840303714569 Optima Coil System (OptiOne Coil System) OPTIONE45M N/A 2026-07-06 00840303714576 Optima Coil System (OptiOne Coil System) OPTIONE45L N/A 2026-07-06 00840303714583 Optima Coil System (OptiOne Coil System) OPTIONE5S N/A 2026-07-06 00840303714590 Optima Coil System (OptiOne Coil System) OPTIONE5M N/A 2026-07-06 00840303714606 Optima Coil System (OptiOne Coil System) OPTIONE5L N/A 2026-07-06 00840303714613 Optima Coil System (OptiOne Coil System) OPTIONE5XL N/A 2026-07-06 00840303714620 Optima Coil System (OptiOne Coil System) OPTIONE55S N/A 2026-07-06 00840303714637 Optima Coil System (OptiOne Coil System) OPTIONE55M N/A 2026-07-06 00840303714644 Optima Coil System (OptiOne Coil System) OPTIONE55L N/A 2026-07-06 00840303714651 Optima Coil System (OptiOne Coil System) OPTIONE55XL N/A 2026-07-06 00840303714668 Optima Coil System (OptiOne Coil System) OPTIONE6S N/A 2026-07-06 00840303714675 Optima Coil System (OptiOne Coil System) OPTIONE6M N/A 2026-07-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840303712053 Prestige Coil System BALT USA LLC KRD 2026-07-14 00840303712077 Prestige Coil System BALT USA LLC KRD 2026-07-14 00840303712091 Prestige Coil System BALT USA LLC KRD 2026-07-14 00840303712107 Prestige Coil System BALT USA LLC KRD 2026-07-14 06958698053355 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053355 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053362 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053362 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053379 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053379 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053386 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053386 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053393 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053393 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053409 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053409 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053416 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053416 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053423 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053423 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053430 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053430 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053447 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053447 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053454 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053454 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053461 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053461 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053478 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. KRD 2026-07-13 06958698053478 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13