FDA.reportPublic FDA data

WallFlex™ Duodenal

Primary DI
08714729456506
Brand
WallFlex™ Duodenal
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00565030
Device description
Stent System with Anchor Lock Delivery System
Published
2015-09-24
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
MUMSTENT,METALLIC,EXPANDABLE,DUODENAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUMStent, Metallic, Expandable, DuodenalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729456506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729456506087147294565068714729456506

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal duodenal stentA sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the duodenum for the palliative treatment of duodenal strictures caused by malignant neoplasms; it is typically used to help eliminate gastric outlet obstructions. It is typically a mesh structure made entirely of metal (e.g., high-grade stainless steel); it is typically expanded in situ (e.g., with a balloon catheter or self-expands) and disposable devices intended to assist implantation may be included.

Device Sizes#

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

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
08714729142201EndoVive Low Profile Replacement ButtonM005627702016-09-24
08714729142218EndoVive Low Profile Replacement ButtonM005628302016-09-24
08714729149200EndoVive™ One Step Button™M00568450M005684502018-09-07
08714729149217EndoVive™ One Step Button™M00568470M005684702018-09-07
08714729149224EndoVive™ One Step Button™M00568500M005685002018-09-07
08714729149231EndoVive™ One Step Button™M00568520M005685202018-09-07
08714729149934EndoVive™ One Step Button™M00568480M005684802018-09-07
08714729149941EndoVive™ One Step Button™M00568530M005685302018-09-07
08714729150084EndoVive™ One Step Button™M00568460M005684602018-09-07
08714729151081EndoVive™ One Step Button™M00568510M005685102018-09-07
08714729284017EndoVive Low Profile Replacement ButtonM005627602016-09-24
08714729284024EndoVive Low Profile Replacement ButtonM005627802016-09-24
08714729284031EndoVive Low Profile Replacement ButtonM005627902016-09-24
08714729284048EndoVive Low Profile Replacement ButtonM005628002016-09-24
08714729284062EndoVive Low Profile Replacement ButtonM005628202016-09-24
08714729284079EndoVive Low Profile Replacement ButtonM005628402016-09-24
08714729284086EndoVive Low Profile Replacement ButtonM005628502016-09-24
08714729821717Radial Jaw 4M005151802016-09-24
08714729821731Radial Jaw 4M005151902016-09-24
08714729821748Radial Jaw 4M005152002016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909414329Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08809909414336Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08809909414343Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08809909414350Niti-S Duodenal Comfort StentTAEWOONGMEDICAL.CO.,LTDMUM2023-06-20
08714729902492WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902508WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902515WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08806367081070HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081100HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081131HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081148HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081179HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081209HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081216HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081247HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081278HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081285HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081315HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367081346HANAROSTENT® LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2019-02-18
08806367076496HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076526HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076557HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076564HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076595HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076625HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076632HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076663HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076694HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076700HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20
08806367076731HANAROSTENT LowAxTM Duodenum/Pylorus(NNN)M.I.Tech Co., Ltd.MUM2018-11-20