FDA.reportPublic FDA data

WallFlex™ Duodenal

Primary DI
08714729456483
Brand
WallFlex™ Duodenal
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00565010
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
08714729456483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729456483087147294564838714729456483

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
08714729749172RX Cholangiogram KitM005714802016-09-24
00191506020729iNod™ Ultrasound Guided Biopsy NeM00502060M005020602023-03-21
00191506020910iNod™ Ultrasound Guidance ConsoM00503210M005032102023-03-21
00191506020927iNod™ Ultrasound Guidance ConsoM0050321R0M0050321R02023-03-21
00191506020934iNod™M00503300M005033002023-03-21
00191506020941iNod™M0050330R0M0050330R02023-03-21
00191506021924iNod™M00503200M005032002023-03-21
00191506021931iNod™M0050320R0M0050320R02023-03-21
08714729860853Expel™ Drainage Catheter with Twist-Loc™ HubH74939341082502016-08-17
08714729860860Expel™ Drainage Catheter with Twist-Loc™ HubH74939341102502016-08-17
08714729860877Expel™ Drainage Catheter with Twist-Loc™ HubH74939341122502016-08-17
08714729860884Expel™ Drainage Catheter with Twist-Loc™ HubH74939341142502016-08-17
08714729860891Expel™ Drainage Catheter with Twist-Loc™ HubH749393410825K12016-08-17
08714729860907Expel™ Drainage Catheter with Twist-Loc™ HubH749393411025K12016-08-17
08714729860914Expel™ Drainage Catheter with Twist-Loc™ HubH749393411225K12016-08-17
00802526623400NA694669462024-08-29
00802526604430INGEVITY™+78402020-02-06
00802526604522INGEVITY™+78422020-02-06
00802526604577INGEVITY™+78412020-02-06
00802526480546NA662866282014-09-24

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