Home GUDID 00840303712435 Optima Coil System
Primary DI 00840303712435
Brand Optima Coil System
Company BALT USA LLC
Model OPTI0212BLK
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 2024-10-07
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
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 00840303712435 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 00840303712435 00840303712435 840303712435 0840303712435
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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840303714262 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714279 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714286 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714293 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714309 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714316 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714323 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714330 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714347 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714354 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714361 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714378 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714385 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714392 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714408 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714415 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714422 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714439 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714446 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714453 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714460 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714477 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00840303714484 Optima Coil System (OptiOne Coil System) BALT USA LLC HCG 2026-01-28 00810169722039 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-01-26 00810169722046 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-01-26 00810169722053 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-01-26 00810169722060 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-01-26 00810169722077 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-01-26 00810169722084 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-01-26 00810169722091 swiftMATCH Coil, Extra Soft PENUMBRA, INC. HCG 2026-01-26