Home GUDID 00818053026829
Optima Coil System
Primary DI 00818053026829
Brand Optima Coil System
Company BALT USA LLC
Model OPTI0508HSS10
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 00818053026829 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 00818053026829 00818053026829 818053026829 0818053026829
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 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 00840303714293 Optima Coil System (OptiOne Coil System) OPTIONE35M 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
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