FDA.reportPublic FDA data

WALLSTENT™ Enteral Endoprosthesis

Primary DI
08714729285083
Brand
WALLSTENT™ Enteral Endoprosthesis
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00565590
Device description
Colonic/Duodenal Stent with UNISTEP™ Plus 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
MQRSTENT, COLONIC, METALIC, EXPANDABLE
MUMSTENT,METALLIC,EXPANDABLE,DUODENAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729285083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729285083087147292850838714729285083

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal colonic stentA sterile non-bioabsorbable tubular device intended to be implanted in the lumen of the colon for the palliative treatment of colonic strictures caused by malignant neoplasms typically in the descending or sigmoid colon, or rectum. It is typically inserted and advanced to the site of implantation with a dedicated catheter, or other instrument, where it self-expands upon release. It is made of metal [e.g., stainless steel or metal alloy such as nickel-titanium alloy (Nitinol)] in a tubular mesh configuration, and is available in various sizes. It will typically be used to relieve large bowel obstruction prior to colectomy, or in patients having high operative risk and/or advanced disease.

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
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14
08714729880318Rhythmia™ Mapping SystemM004RBLMR1002016-09-24
08714729938736RHYTHMIA HDx™M004RH20010M004RH200102017-05-03
08714729832089Rubicon™ 18H749392390180902016-09-24
08714729832096Rubicon™ 35H749392400350902016-09-24
08714729832102Rubicon™ 35H749392400351502016-09-24
08714729832119Rubicon™ 35H749392400350602016-09-24
08714729832126Rubicon™ 35H749392400351302016-09-24
08714729832133Rubicon™ 14H749392120141302016-09-24
08714729832140Rubicon™ 14H749392120141502016-09-24
08714729832157Rubicon™ 18H749392390181302016-09-24
08714729832164Rubicon™ 18H749392390181502016-09-24
00191506019563Rubicon™ ControlH749394321409A0H749394321409A02024-02-16
00191506019587Rubicon™ ControlH749394321413A0H749394321413A02024-02-16
00191506019600Rubicon™ ControlH749394321415A0H749394321415A02024-02-16
00191506019624Rubicon™ ControlH749394321809A0H749394321809A02024-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536219681Small VBR (ADD)Ulrich GmbH & Co. KGMQR2026-03-03
04052536219605ADDUlrich GmbH & Co. KGMQR2025-08-25
04052536009510ADDUlrich GmbH & Co. KGMQR2024-10-29
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
08809909414367Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414374Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414381Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414398Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414404Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414411Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414428Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08809909414435Niti-S Colonic Comfort StentTAEWOONGMEDICAL.CO.,LTDMQR2023-06-20
08714729902492WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902508WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902515WallFlex™ DuodenalBOSTON SCIENTIFIC CORPORATIONMUM2020-05-26
08714729902584WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08714729902591WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08714729902607WallFlex™ ColonicBOSTON SCIENTIFIC CORPORATIONMQR2020-05-26
08806367080790HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080820HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080851HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080868HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080899HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080929HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-03-11
08806367080516HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080547HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18
08806367080578HANAROSTENT® LowAxTM Colon/Rectum(NNN)M.I.Tech Co., Ltd.MQR2019-02-18