Comaneci 17

Primary DI
07290015107150
Brand
Comaneci 17
Company
RAPID MEDICAL LTD
Model
ANPP7199
Device description
The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath.
Published
2019-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PUUTemporary Coil Embolization Assist Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUUTemporary Coil Embolization Assist DeviceNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN170064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170064000Comaneci, Comaneci Petit, Comaneci 17Rapid-Medical , Ltd.2019-04-24PUU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290015107157PackageGS13In Commercial Distribution
27290015107154PackageGS14In Commercial Distribution
37290015107151PackageGS12In Commercial Distribution
07290015107150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001510715717290015107157
2729001510715427290015107154
3729001510715137290015107151
07290015107150072900151071507290015107150

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.

Regulatory Flags#

DUNS number
532702946
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015107372BraidE Embolization Assist DeviceBRPP70042026-04-14
07290015107303Tigertriever 13 Revascularization DeviceTRPP7144TRPP71442022-07-28
07290015107266Tigertriever Revascularization DeviceTRPP7155TRPP71552021-04-05
07290015107273Tigertriever 17 Revascularization DeviceTRPP71662021-04-05
07290015107341Tigertriever 25 Revascularization DeviceTRPP71252026-03-16
07290015107402Tigertriever 17 Ultra Revascularization DeviceTRPP72662025-11-17
07290015107358Drivewire 24 Guidewire DRPP24112025-04-06
17290015107300Tigertriever 13 Revascularization DeviceTRPP7144TRPP71442022-07-28
07290015107235Drivewire LRDRLR74642021-08-26
07290015107242Drivewire SRDRSR74632021-08-26
07290015107136ComaneciANPP71772019-05-17
07290015107143Comaneci Petit ANPP71882019-05-17
27290015107154Comaneci 17 ANPP71992019-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290015107136ComaneciRAPID MEDICAL LTDPUU2019-05-17
07290015107143Comaneci Petit RAPID MEDICAL LTDPUU2019-05-17
27290015107154Comaneci 17 RAPID MEDICAL LTDPUU2019-05-17