FDA.reportPublic FDA data

Starter™ Guidewire

Primary DI
08714729172031
Brand
Starter™ Guidewire
Company
LAKE REGION MEDICAL LIMITED
Model
M001491351
Catalog number
49-135
Device description
"""J"" Curved Moveable Core Guidewire"
Published
2016-11-06
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
08714729743156PackageGS110In Commercial Distribution
08714729172031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729743156087147297431568714729743156
08714729172031087147291720318714729172031

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
Length150Centimeter
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
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
08714729326618Starter™ GuidewireM00149136149-1362016-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07
06947358524021Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06947358535454Sunmed™ guide wiresSunny Medical Device (Shenzhen) Co., Ltd.DQX2026-07-07
06971428595857DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595864DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595871DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595888DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595895DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595901DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595918DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
06971428595925DCwire™Shanghai Achieva Medical Suzhou Co., Ltd.DQX2026-07-03
00816349014994CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015007CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015014CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015021CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015038CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015045CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015052CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015069CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015076CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349015083CPS Courier GuidewireBRIVANT LIMITEDDQX2026-06-26
00816349012570Safari2Lake Region MedicalDQX2026-06-25
00816349012587Safari2Lake Region MedicalDQX2026-06-25
00816349012594Safari2Lake Region MedicalDQX2026-06-25
00816349013676WallStentLake Region MedicalDQX2026-06-25
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30