FDA.reportPublic FDA data

Axios™

Primary DI
08714729904632
Brand
Axios™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00553750
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
08714729904632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729904632087147299046328714729904632

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
08714729270133Polaris X™M0047000D0M0047000D02016-09-24
08714729270140Polaris X™M0047001D0M0047001D02016-09-24
08714729270164Polaris X™M0047003D0M0047003D02016-09-24
08714729270171Polaris X™M0047004D0M0047004D02016-09-24
08714729270188Polaris X™M0047005D0M0047005D02016-09-24
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

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
08714729904625Axios™BOSTON SCIENTIFIC CORPORATIONPCU2015-10-13