FDA.reportPublic FDA data

WALLSTENT® Endoprosthesis

Primary DI
08714729204046
Brand
WALLSTENT® Endoprosthesis
Company
BOSTON SCIENTIFIC CORPORATION
Model
H965403320
Catalog number
H965403320
Device description
Self-Expanding Stent
Published
2015-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAFSTENT, CORONARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAFStent, CoronaryUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729204046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729204046087147292040468714729204046

GMDN Terms#

Term, Definition table
TermDefinition
Multiple peripheral artery stent, bare-metalA non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021717889
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00685447020677RFP-100A™ RF Puncture GeneratorM004RFP100A0M004RFP100A02026-06-08
00191506049232Orbera™M00505670M005056702026-06-04
08714729121190Ultraflex™ Esophageal NGM005142002015-09-24
08714729121206Ultraflex™ Esophageal NGM005142102015-09-24
08714729121213Ultraflex™ Esophageal NGM005142202015-09-24
08714729121220Ultraflex™ Esophageal NGM005142302015-09-24
08714729649113Ultraflex™ Esophageal NGM005137502015-09-24
08714729716075Ultraflex™ Esophageal NGM005138502015-09-24
08714729716082Ultraflex™ Esophageal NGM005138602015-09-24
08714729716099Ultraflex™ Esophageal NGM005138402015-09-24
08714729716105Ultraflex™ Esophageal NGM005142402015-09-24
08714729716112Ultraflex™ Esophageal NGM005142502015-09-24
08714729716129Ultraflex™ Esophageal NGM005137002015-09-24
08714729716136Ultraflex™ Esophageal NGM005137102015-09-24
08714729716143Ultraflex™ Esophageal NGM005137202015-09-24
08714729716150Ultraflex™ Esophageal NGM005137302015-09-24
08714729716167Ultraflex™ Esophageal NGM005137402015-09-24
08714729716174Ultraflex™ Esophageal NGM005138002015-09-24
08714729716181Ultraflex™ Esophageal NGM005138102015-09-24
08714729716198Ultraflex™ Esophageal NGM005138202015-09-24

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
08714729204053WALLSTENT® EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729406433WALLSTENT™ RP EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24
08714729406457WALLSTENT™ RP EndoprosthesisBOSTON SCIENTIFIC CORPORATIONMAF2015-03-24