FDA.reportPublic FDA data

TRUFILL

Primary DI
10886704029410
Brand
TRUFILL
Company
Cerenovus, Inc.
Model
635-002
Catalog number
635002
Device description
TRUFILL DCS Syringe II
Published
2015-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063254000
K080967000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063254000THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEMCordis Neurovascular, Inc.2006-12-07HCG
K080967000TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBITCordis Neurovascular, Inc.2008-05-02HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704029410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670402941010886704029410

GMDN Terms#

Term, Definition table
TermDefinition
Embolization implant syringeA sterile hollow barrel fitted with a threaded plunger and a pressure gauge, designed to place an embolic implant in the body. The device provides precise pressure control for the preparation (purging) and release of an implantable device after it has been surgically positioned at the target site using a delivery tube (e.g., an appropriate catheter). The plunger has a locking mechanism for added control, and the device comes equipped with a flexible, high-pressure extension tube. The pressure gauge will typically facilitate settings for purging, implant placement, and detachment (launch). This is a single-use device.

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
10886704085324TRUFILL632400NA632400NA2023-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327635096InZone ISTStryker CorporationHCG2026-07-08
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714675Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714682Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
00840303714699Optima Coil System (OptiOne Coil System)BALT USA LLCHCG2026-07-06
M242RBYPODJ150PODPENUMBRA, INC.HCG2024-08-15
M424RBYPODJ150PODPENUMBRA, INC.HCG2016-08-01
M424RBYPODJ600PODPENUMBRA, INC.HCG2016-08-01
M424RBYPODJ450PODPENUMBRA, INC.HCG2016-08-01
M4244002C03060Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C03100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04080Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C04120Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C05060Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C05100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30
M4244002C06100Penumbra Coil 400PENUMBRA, INC.HCG2016-07-30