FDA.reportPublic FDA data

TRUFILL

Primary DI
10886704085324
Brand
TRUFILL
Company
Cerenovus, Inc.
Model
632400NA
Catalog number
632400NA
Device description
TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: (2) 1 g n-BCA, self-piercing caps, 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
10886704085324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408532410886704085324

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
10886704085317TRUFILL632500NA632500NA2023-10-23
10886704029144TRUFILL631-400631-4002014-09-20
10886704029151TRUFILL631-500631-5002014-09-20
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086512CEREGLIDENIC57125UNIC57125U2025-09-26
10886704086536CEREGLIDENIC57132UNIC57132U2025-09-26
10886704086550CEREGLIDENIC57137UNIC57137U2025-09-26
10886704086598CEREGLIDENIC42125U2025-09-26
10886704086611CEREGLIDENIC42115U2025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886704085317TRUFILLCerenovus, Inc.SGU2023-10-23
10886704085317TRUFILLCerenovus, Inc.KGG2023-10-23
10886704029144TRUFILLCerenovus, Inc.SGU2014-09-20
10886704029144TRUFILLCerenovus, Inc.KGG2014-09-20
10886704029151TRUFILLCerenovus, Inc.SGU2014-09-20
10886704029151TRUFILLCerenovus, Inc.KGG2014-09-20