Optima Coil System N/A

GUDID 00818053022142

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.

BALT USA LLC

Neurovascular embolization coil

• Primary Device ID: 00818053022142
• NIH Device Record Key: c7af6d0e-4fc8-4be7-aa24-fc7b6bb41b02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optima Coil System
• Version Model Number: OPTI0153HSS10
• Catalog Number: N/A
• Company DUNS: 945543689
• Company Name: BALT USA LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com
• Phone: 1-949-788-1443
• Email: customerservice@balt-usa.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store at a controlled room temperature in a dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818053022142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172390

FDA Product Code

• HCG: Device, Neurovascular Embolization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-02
• Device Publish Date: 2018-09-01

On-Brand Devices [Optima Coil System]

• 00818053024344: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024337: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024320: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024313: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024306: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024290: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024283: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024276: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024269: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024252: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024245: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024238: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024221: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024214: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024207: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024191: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024184: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024177: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024160: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024153: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024146: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024139: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024122: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024115: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024108: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024092: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024085: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024078: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024061: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024054: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024047: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024030: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024023: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024016: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053024009: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023996: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023989: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023972: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023965: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023958: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023941: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023934: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023927: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023910: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023903: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023897: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023880: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023873: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023866: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and
• 00818053023859: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and