FDA.reportPublic FDA data

TRUFILL

Primary DI
10886704085317
Brand
TRUFILL
Company
Cerenovus, Inc.
Model
632500NA
Catalog number
632500NA
Device description
TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: 1 g n-BCA, self-piercing cap, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels
Published
2023-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGGtissue adhesive for use in embolization of brain arteriovenous malformations
SGUNeurovascular Liquid Embolic Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous MalformationsUnknown3
SGUNeurovascular Liquid Embolic AgentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P990040031
P990040034

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P990040031TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEMCerenovus, Inc.2000-09-25KGG
P990040034TRUFILL N-BUTYL CYANOACRYLATE LIQUID EMBOLIC SYSTEMCerenovus, Inc.2000-09-25KGG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704085317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408531710886704085317

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704080428ENPOWERDCB2000500DCB20005002016-09-12
10886704082293CEREBASEGS9090SDGS9090SD2020-04-13
10886704082316CEREBASEGS9080SDGS9080SD2020-04-13
10886704082323CEREBASEGS9095SDGS9095SD2020-04-13
10886704076957DELTAFILLDLF100154DLF1001542016-11-16
10886704076971DELTAFILLDLF100250DLF1002502016-11-16
10886704076988DELTAFILLDLF100258DLF1002582016-11-16
10886704077022DELTAFILLDLF100208DLF1002082016-11-16
10886704077039DELTAFILLDLF100310DLF1003102016-11-16
10886704077046DELTAFILLDLF100308DLF1003082016-11-16
10886704077053DELTAFILLDLF100410DLF1004102015-09-20
10886704077060DELTAFILLDLF100408DLF1004082015-09-20
10886704077077DELTAFILLDLF100510DLF1005102016-11-16
10886704077176DELTAFILLDLF182260DLF1822602016-11-16
10886704077183DELTAFILLDLF182460DLF1824602016-11-16
10886704077244DELTAXSFTDLX100151DLX1001512015-09-20
10886704077251DELTAXSFTDLX100152DLX1001522015-09-20
10886704077268DELTAXSFTDLX100153DLX1001532015-09-20
10886704077275DELTAXSFTDLX100254DLX1002542015-09-20
10886704077282DELTAXSFTDLX100256DLX1002562015-09-20

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
00840303713296SQUID 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
10886704085324TRUFILLCerenovus, Inc.SGU2023-10-23
10886704085324TRUFILLCerenovus, Inc.KGG2023-10-23
10886704029144TRUFILLCerenovus, Inc.SGU2014-09-20
10886704029144TRUFILLCerenovus, Inc.KGG2014-09-20
10886704029151TRUFILLCerenovus, Inc.SGU2014-09-20
10886704029151TRUFILLCerenovus, Inc.KGG2014-09-20