FDA.reportPublic FDA data

Axios™

Primary DI
08714729904625
Brand
Axios™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00553740
Device description
Stent and Delivery System
Published
2015-10-13
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
PCUpancreatic stent, covered, metallic, removable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCUPancreatic Stent, Covered, Metallic, RemovableGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729904625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729904625087147299046258714729904625

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-metal biliary stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed biliary duct (e.g., common bile duct) to maintain luminal patency. It is a mesh structure made of metal which is covered/lined with a synthetic polymer material (e.g., silicone) that prevents lateral flow and tissue ingrowth and facilitates removability. 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

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
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909422287Niti-S SPAXUS StentTAEWOONGMEDICAL.CO.,LTDPCU2026-03-23
08809909422294Niti-S SPAXUS StentTAEWOONGMEDICAL.CO.,LTDPCU2026-03-23
08809909422300Niti-S SPAXUS StentTAEWOONGMEDICAL.CO.,LTDPCU2026-03-23
00191506008086Axios™BOSTON SCIENTIFIC CORPORATIONPCU2021-05-27
00191506008093Axios™BOSTON SCIENTIFIC CORPORATIONPCU2021-05-27
08714729979333Axios™BOSTON SCIENTIFIC CORPORATIONPCU2019-11-25
08714729951179Axios™BOSTON SCIENTIFIC CORPORATIONPCU2017-06-08
08714729904588Axios™BOSTON SCIENTIFIC CORPORATIONPCU2015-10-20
08714729904595Axios™BOSTON SCIENTIFIC CORPORATIONPCU2015-10-20
08714729904632Axios™BOSTON SCIENTIFIC CORPORATIONPCU2015-10-13