FDA.reportPublic FDA data

NIRxcell CoCr Coronary Stent on RX System

Primary DI
07290107010849
Brand
NIRxcell CoCr Coronary Stent on RX System
Company
MEDINOL LTD.
Model
NXL27528US
Published
2014-10-01
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
MAFStent, Coronary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAFStent, CoronaryUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P110004001
P110004002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P110004001PRESILLION PLUS COCR CORONARY STENT RX SYSTEMMedinol, Ltd.2012-04-12MAF
P110004002PRESILLION PLUS COCR CORONARY STENT RX SYSTEMMedinol, Ltd.2012-04-12MAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107010849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107010849072901070108497290107010849

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal coronary artery stentA non-bioabsorbable tubular device [bare metal stent (BMS)] intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. It is typically made of high-grade stainless steel or cobalt-chrome (Co-Cr), may be linear or have a bifurcation design (e.g., shaped as a Y in a tube form), and may be balloon-expanded or self-expandable. Dedicated disposable implantation devices (e.g., balloon catheter, delivery instrument) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter
Outer Diameter2.75Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-477-5801xxx@xxx.xxx

Regulatory Flags#

DUNS number
600593800
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R12US2017-12-18
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R15US2017-12-18
07290107013543EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R17US2017-12-18
07290107013550EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R20US2017-12-18
07290107013567EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R24US2017-12-18
07290107013574EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R28US2017-12-18
07290107013581EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R33US 2017-12-18
07290107013598EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R08US2017-12-18
07290107013604EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R12US2017-12-18
07290107013611EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R15US 2017-12-18
07290107013628EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R17US2017-12-18
07290107013635EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R20US2017-12-18
07290107013642EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R24US2017-12-18
07290107013659EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R28US2017-12-18
07290107013666EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R33US 2017-12-18
07290107013697EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R08US2017-12-18
07290107013703EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R12US2017-12-18
07290107013710EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R15US 2017-12-18
07290107013727EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R17US 2017-12-18
07290107013734EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R20US2017-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00894588002125Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002132Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002149Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002156Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002163Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002170Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
00894588002187Tryton Side Branch StentTRYTON MEDICAL, INC.MAF2017-03-02
10705032064736PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076197PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076234PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
10705032076241PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-05-07
20705032057285PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057261PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057247PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
20705032057346PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-05-07
10705032076227PALMAZ Balloon Expandable StentCordis US Corp.MAF2015-04-29
20705032057223PALMAZ Balloon Expandable StentCORDIS CORPORATIONMAF2015-04-29
08714729203940WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203957WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203964WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203971WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203988WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729203995WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204008WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204015WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204022WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204039WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204046WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729204053WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729406433WALLSTENT™ RP EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24