FDA.reportPublic FDA data

Starter™ Guidewire

Primary DI
08714729326731
Brand
Starter™ Guidewire
Company
LAKE REGION MEDICAL LIMITED
Model
M001491561
Catalog number
49-156
Device description
Rosen Guidewire
Published
2016-11-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
08714729743293PackageGS15In Commercial Distribution
08714729326731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729743293087147297432938714729743293
08714729326731087147293267318714729326731

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length180Centimeter
Outer Diameter0.035Inch

Contacts#

Phone, Email table
PhoneEmail
888-272-1001xx@xx.xx

Regulatory Flags#

DUNS number
988555595
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08714729172031Starter™ GuidewireM00149135149-1352016-11-06
08714729201298Starter™ GuidewireM00149110149-1102016-11-03
08714729201304Starter™ GuidewireM00149118149-1182016-11-06
08714729201311Starter™ GuidewireM00149132149-1322016-11-06
08714729201328Starter™ GuidewireM00149145149-1452016-11-07
08714729326458Starter™ GuidewireM00149100149-1002016-11-03
08714729326472Starter™ GuidewireM00149103149-1032016-11-03
08714729326489Starter™ GuidewireM00149111149-1112016-11-04
08714729326496Starter™ GuidewireM00149115149-1152016-11-04
08714729326502Starter™ GuidewireM00149116149-1162016-11-04
08714729326519Starter™ GuidewireM00149117149-1172016-11-04
08714729326526Starter™ GuidewireM00149119149-1192016-11-06
08714729326533Starter™ GuidewireM00149120149-1202016-11-06
08714729326540STARTER™ GUIDEM00149121149-1212016-11-06
08714729326557Starter™ GuidewireM00149122149-1222016-11-06
08714729326564Starter™ GuidewireM00149123149-1232016-11-06
08714729326571Starter™ GuidewireM00149130149-1302016-11-06
08714729326588Starter™ GuidewireM00149131149-1312016-11-06
08714729326595Starter™ GuidewireM00149133149-1332016-11-06
08714729326601Starter™ GuidewireM00149134149-1342016-11-06

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