FDA.reportPublic FDA data

TRUPUSH

Primary DI
10886704029168
Brand
TRUPUSH
Company
Cerenovus, Inc.
Model
632-774X
Catalog number
632774X
Device description
TRUPUSH Coil Pusher 50 cm Coil Push Diameter .017 Inches (0.43 mm) Usable Length 195 cm
Published
2015-09-20
Public version status
Update
Distribution status
Not 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
K071962000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071962000VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)Cordis Neurovascular, Inc.2007-09-26HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704029168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670402916810886704029168

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

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
06958698053355Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053362Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053379Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053386Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053393Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053409Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053416Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053423Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053430Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053447Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053454Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053461Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053478Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053485Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053492Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
06958698053508Numen HeliaMicroPort NeuroTech (Shanghai) Co., Ltd.HCG2026-07-13
00816777020116V-Grip Detachment ControllerMicrovention, Inc.HCG2025-08-28
00840273202028V-Grip Detachment ControllerMicrovention, Inc.HCG2025-08-28
00842429106464V-Grip Detachment ControllerMicrovention, Inc.HCG2025-08-28
10886704080121GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080138GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080145GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080152GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080206GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080213GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080220GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080237GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080244GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080251GALAXY G3Cerenovus, Inc.HCG2017-11-03
10886704080268GALAXY G3Cerenovus, Inc.HCG2017-11-03