FDA.reportPublic FDA data

CERENOVUS ENTERPRISE

Primary DI
10886704044017
Brand
CERENOVUS ENTERPRISE
Company
Medos International Sàrl
Model
ENF451412
Catalog number
ENF451412
Device description
CERENOVUS ENTERPRISE Vascular Reconstruction Device and Delivery System Unconstrained Stent OD 4.5mm Unconstrained Stent Length 14mm. 12mm Distal tip. Maximum Stent foreshortening 1.1mm, Recommended Microcatheter .021inch(0.533mm)
Published
2014-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NJEintracranial neurovascular stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJEIntracranial Neurovascular StentUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H060001012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H060001012

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704044017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670404401710886704044017

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal intracranial vascular stentA non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if opened or damaged.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034647807TRIALTIS5161-00-514551610051452026-06-03
10705034647814TRIALTIS5161-00-514451610051442026-06-03
10705034647821TRIALTIS5161-00-514051610051402026-06-03
10705034647838TRIALTIS5161-00-514651610051462026-06-03
10705034648118TRIALTIS5161-00-514151610051412026-06-03
10886705028139NA2420552420552017-03-29
10886705030187NA2426322426322018-02-22
10886705030194NA2426332426332018-02-22
10886705030200NA2426342426342018-02-22
10886705030217NA2426352426352018-02-22
10886705030224NA2426362426362018-02-22
10886705030231NA2426372426372018-02-22
10886705030248NA2426382426382018-02-22
10886705030255NA2426392426392018-02-22
10886705030262NA2426402426402018-02-22
10886705030279NA2426522426522018-02-22
10886705030286NA2426532426532018-02-22
10886705030293NA2426542426542018-02-22
10705034606897TRIALTIS5560886545S5560886545S2026-05-29
10705034608679TRIALTIS5560520004S5560520004S2026-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00816777025999LVISMicrovention, Inc.NJE2018-11-25
00816777026002LVISMicrovention, Inc.NJE2018-11-25
00816777026019LVISMicrovention, Inc.NJE2018-11-25
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00810170014420LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014437LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014451LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170014468LVIS Jr.Microvention, Inc.NJE2018-11-25
00810170016288LVISMicrovention, Inc.NJE2018-11-25
00810170016295LVISMicrovention, Inc.NJE2018-11-25
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00810170016332LVISMicrovention, Inc.NJE2018-11-25
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00810170018510LVIS Jr.Microvention, Inc.NJE2018-11-25
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00810170018619LVISMicrovention, Inc.NJE2018-11-25
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