FDA.reportPublic FDA data

WALLSTENT™ BILIARY

Primary DI
08714729204657
Brand
WALLSTENT™ BILIARY
Company
BOSTON SCIENTIFIC CORPORATION
Model
H965430300
Device description
Endoscopic Biliary Endoprosthesis
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
ESWPROSTHESIS, ESOPHAGEAL
FGECATHETER, BILIARY, DIAGNOSTIC
JCTProsthesis, tracheal, expandable
MQRSTENT, COLONIC, METALIC, EXPANDABLE
MUMSTENT,METALLIC,EXPANDABLE,DUODENAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESWProsthesis, EsophagealGeneral, Plastic Surgery2
FGEStents, Drains And Dilators For The Biliary DuctsGastroenterology, Urology2
JCTProsthesis, Tracheal, ExpandableGeneral, Plastic Surgery2
MQRStent, Colonic, Metallic, ExpandableGeneral, Plastic Surgery2
MUMStent, Metallic, Expandable, DuodenalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729204657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729204657087147292046578714729204657

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal biliary stentA non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency; it is not intended for vascular implantation. It may be a mesh structure or a continuous tube and is made entirely of metal [e.g., high-grade stainless steel, cobalt-chrome (Co-Cr), nickel-titanium alloy (Nitinol)]. It may be expandable 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

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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