Barricade Coil System DETACHMENT CONTROLLER

GUDID 00818053021367

Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The BCS is also intended 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 embolizations in the peripheral vasculature. The BCS consists of an implantable coil attached to a delivery pusher. The delivery pusher is powered by the Blockade Detachment Controller (BDC) designed specifically for the BCS. The device comes pre-loaded with one 9-volt battery. A BlockWire Connecting Cable or Handheld Detachment Cable, comprised of a red and black cable leads are required to detach Barricade Detachable Coils and must be used in conjunction with a return electrode.

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 Neurovascular embolization coil
Primary Device ID00818053021367
NIH Device Record Key69af9fda-ccb5-4f44-af9e-99649ee7829d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarricade Coil System
Version Model Number900067
Catalog NumberDETACHMENT CONTROLLER
Company DUNS945543689
Company NameBALT USA LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx
Phone949-788-1443
Emailxxx@xx.xx

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100818053021367 [Primary]

FDA Product Code

HCGDevice, Neurovascular Embolization

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

[00818053021367]

Radiation Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-09
Device Publish Date2017-09-01

On-Brand Devices [Barricade Coil System]

00818053021367Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021350Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021343Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021336Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021329Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021312Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021305Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021299Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021282Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021275Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021268Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021251Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021244Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021237Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021220Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021213Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021206Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021190Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021183Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021176Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021169Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021152Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021145Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021138Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021121Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021114Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021107Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021091Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021084Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021077Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021060Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021053Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021046Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021039Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021022Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021015Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053021008Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020995Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020988Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020971Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020964Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020957Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020940Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020933Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020926Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020919Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020902Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020896Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020889Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
00818053020872Barricade Coil System (BCS) is intended for the endovascular embolization of intracranial aneury
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