FDA.reportPublic FDA data

EXTENSION

Primary DI
04547327083577
Brand
EXTENSION
Company
ASAHI INTECC CO., LTD.
Model
AG149001
Published
2020-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, guide, catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547327083574PackageGS15In Commercial Distribution
04547327083577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454732708357414547327083574
04547327083577045473270835774547327083577

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery guidewire extensionA long, thin, sterile wire designed to provide the necessary length to allow the exchange of one coronary artery dilatation catheter for another, while maintaining the position of the cardiac catheter guidewire in the coronary artery, during angiography or percutaneous transluminal coronary angioplasty (PTCA). It is typically made of polymer-coated [e.g., polytetrafluoroethylene (PTFE)] stainless steel and supplied with a guidewire extension insertion device to facilitate its joining to the proximal end of the in situ guidewire. After the catheter exchange, the guidewire extension can be detached and the guidewire used as intended. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length165Centimeter
Outer Diameter0.014Inch

Regulatory Flags#

DUNS number
690711189
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547327166140SAYA 86SY86-7A80D2026-06-12
04547327166157SAYA 86SY86-7A90D2026-06-12
04547327166164SAYA 86SY86-7A95D2026-06-12
04547327166171SAYA 86SY86-7A100D2026-06-12
04547327166188SAYA 86SY86-7A105D2026-06-12
04547327166195SAYA 86SY86-7A110D2026-06-12
04547327166201SAYA 86SY86-7S80D2026-06-12
04547327166218SAYA 86SY86-7S90D2026-06-12
04547327166225SAYA 86SY86-7S95D2026-06-12
04547327166232SAYA 86SY86-7S100D2026-06-12
04547327166249SAYA 86SY86-7S105D2026-06-12
04547327166256SAYA 86SY86-7S110D2026-06-12
04547327087988TornusAT241352016-09-16
04547327087995TornusAT351352016-09-16
04547327090322SheathLess EaucathG6JL35-0-L1002016-09-16
04547327090339SheathLess EaucathG6JL35-0-L100S2016-09-16
04547327090346SheathLess EaucathG6JL40-0-L1002016-09-16
04547327090353SheathLess EaucathG6JL40-0-L100S2016-09-16
04547327090360SheathLess EaucathG6JL45-0-L1002016-09-16
04547327090377SheathLess EaucathG6JL45-0-L100S2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540184010127OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDQX2026-09-30
07540184020034OptoMOnitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDQX2026-09-30
07540184020058OptoMonitorOpsens IncDQX2026-09-30
07540184020065OptoMonitorOpsens IncDQX2026-09-30
07540184020072OptoMonitorOpsens IncDQX2026-09-30
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
10801902226614ARROWTELEFLEX INCORPORATEDDQX2026-08-28
00884450529300SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529713SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529829SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450590010SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450631928InQwire® AmplatzMerit Medical Systems, Inc.DQX2026-08-21
00884450731789InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00884450739709InQwire®Merit Medical Systems, Inc.DQX2026-08-21
10801902226430ARROWTELEFLEX INCORPORATEDDQX2026-08-10
10801902206241ARROWTELEFLEX INCORPORATEDDQX2026-08-03
10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
04547327167215CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29