FDA.reportPublic FDA data

RUNTHROUGH

Primary DI
54987350703786
Brand
RUNTHROUGH
Company
TERUMO CORPORATION
Model
25-9092
Catalog number
TW*JJ415Z
Device description
RUNTHROUGH NS Extension Wire
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
54987350703786PackageGS110In Commercial Distribution
04987350703781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5498735070378654987350703786
04987350703781049873507037814987350703781

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
Length150Centimeter
Outer Diameter0.36Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedica

Regulatory Flags#

DUNS number
690543319
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987350739124CAPIOXCX*FX05WACX*FX05WA2021-07-06
04987350739100CAPIOXCX*FX05EACX*FX05EA2021-07-01
04987350781710CAPIOX®FXCX*FX05E2015-09-15
04987350781734CAPIOX®FXCX*FX05W2015-09-15
04987350383075HEARTRAIL40-6370GC-U6IL350N2016-09-09
04987350383099HEARTRAIL40-6371GC-U6IL350A2016-09-09
04987350383112HEARTRAIL40-6372GC-U6IL3G0N2016-09-09
04987350383136HEARTRAIL40-6373GC-U6IL400N2016-09-09
04987350383150HEARTRAIL40-6374GC-U6IL400A2016-09-09
04987350383174HEARTRAIL40-6375GC-U6IL450N2016-09-09
04987350383198HEARTRAIL40-6376GC-U6IL450A2016-09-09
04987350383235HEARTRAIL40-6380GC-U6IR100N2016-09-09
04987350383259HEARTRAIL40-6381GC-U6IR150N2016-09-09
04987350383273HEARTRAIL40-6382GC-U6IR200N2016-09-09
04987350423795HEARTRAIL40-6383GC-U6IR100A2016-09-09
04987350423818HEARTRAIL40-6385GC-U6IR200A2016-09-09
04987350423832HEARTRAIL40-6377GC-U6IL3G0A2016-09-09
04987350423856HEARTRAIL40-6384GC-U6IR150A2016-09-09
04987350423870HEARTRAIL40-6311GC-U6TG400N2016-09-09
04987350703163FINECROSS35-1430NC*F863A2016-09-09

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