Home GUDID 00818053026751
Optima Coil System
Primary DI 00818053026751
Brand Optima Coil System
Company BALT USA LLC
Model OPTI0306HSS10
Catalog number N/A
Device description The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller.
Published 2020-02-28
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
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HCG Device, Neurovascular Embolization Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00818053026751 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 00818053026751 00818053026751 818053026751 0818053026751
GMDN Terms# Term, Definition table Term Definition Neurovascular embolization coil A sterile, 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 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 06958698053355 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053362 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053379 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053386 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 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 06958698053416 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053423 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053430 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053447 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053454 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053461 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053478 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053485 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053492 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 06958698053508 Numen Helia MicroPort NeuroTech (Shanghai) Co., Ltd. HCG 2026-07-13 07613327635096 InZone IST Stryker Corporation HCG 2026-07-08 00840303714521 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714538 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714545 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714552 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714569 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714576 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714583 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714590 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714606 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714613 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714620 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714637 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06 00840303714644 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-07-06