Optima Coil System N/A

GUDID 00818053025280

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 Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil
Primary Device ID00818053025280
NIH Device Record Key0a4c26e6-e345-474f-abde-65e795c09f0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptima Coil System
Version Model NumberOPTI1040CSFMX
Catalog NumberN/A
Company DUNS945543689
Company NameBALT USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at a controlled room temperature in a dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100818053025280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRDDevice, Vascular, For Promoting Embolization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-02-28

On-Brand Devices [Optima Coil System]

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

Trademark Results [Optima Coil System]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OPTIMA COIL SYSTEM
OPTIMA COIL SYSTEM
87266088 5586890 Live/Registered
Blockade Medical LLC, a Balt Company
2016-12-12

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