FDA.reportPublic FDA data

SQUID Liquid Embolic Agent

Primary DI
00840303713296
Brand
SQUID Liquid Embolic Agent
Company
BALT USA LLC
Model
SQUID12LD3MLKIT
Catalog number
N/A
Device description
SQUID is a non-adhesive, Liquid Embolic Agent (LEA) consisting of an Ethylene Vinyl Alcohol (EVOH) copolymer dissolved in Dimethyl Sulfoxide (DMSO) and suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy. The SQUID consists of a vial of SQUID, a vial of DMSO, SQUID delivery syringe(s), one DMSO delivery syringe, syringe adapter(s) and stickers to identify the vials of SQUID.
Published
2026-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SGUNeurovascular Liquid Embolic Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGUNeurovascular Liquid Embolic AgentUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840303713296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840303713296008403037132968403037132960840303713296

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization plugA non-bioabsorbable material (e.g., gel, liquid) intended to be implanted in a neurovascular blood vessel, to obstruct blood flow to treat a brain arteriovenous malformation (bAVM). It may be supplied as a liquid [e.g., ethylene vinyl alcohol (EVOH)], gel or powder intended to solidify or expand in situ to create a barrier to blood flow (embolus); it contains no pharmaceutical agents. It may be supplied with dedicated instruments for implantation.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place at room temperature and away from light.

Contacts#

Phone, Email table
PhoneEmail
1-949-788-1443customerservice@balt-usa.com

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 DIBrandModelCatalogPublished
00840303714521Optima Coil System (OptiOne Coil System)OPTIONE4SN/A2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)OPTIONE4MN/A2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)OPTIONE4LN/A2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)OPTIONE45SN/A2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)OPTIONE45MN/A2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)OPTIONE45LN/A2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)OPTIONE5SN/A2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)OPTIONE5MN/A2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)OPTIONE5LN/A2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)OPTIONE5XLN/A2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)OPTIONE55SN/A2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)OPTIONE55MN/A2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)OPTIONE55LN/A2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)OPTIONE55XLN/A2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)OPTIONE6SN/A2026-07-06
00840303714675Optima Coil System (OptiOne Coil System)OPTIONE6MN/A2026-07-06
00840303714682Optima Coil System (OptiOne Coil System)OPTIONE6LN/A2026-07-06
00840303714699Optima Coil System (OptiOne Coil System)OPTIONE6XLN/A2026-07-06
00840303707295SQUID Liquid Embolic AgentSQUID12KITN/A2026-06-23
00840303713173SQUID Liquid Embolic AgentSQUID12LDKITN/A2026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840303707295SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713173SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713180SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713197SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713265SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713272SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713289SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713302SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713319SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713326SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
00840303713333SQUID Liquid Embolic AgentBALT USA LLCSGU2026-06-23
10886704085317TRUFILLCerenovus, Inc.SGU2023-10-23
10886704085324TRUFILLCerenovus, Inc.SGU2023-10-23
10886704029144TRUFILLCerenovus, Inc.SGU2014-09-20
10886704029151TRUFILLCerenovus, Inc.SGU2014-09-20