FDA.reportPublic FDA data

Spring Coil Guidewire

Primary DI
00857834006391
Brand
Spring Coil Guidewire
Company
HERAEUS MEDICAL COMPONENTS LLC
Model
SCG-005
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143135000Spring Coil GuidewireNeometrics, Inc.2015-02-20DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857834006391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857834006391008578340063918578340063910857834006391

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
868303074
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002448469Motion Hybrid Wire GuideMHW-0351502021-09-09
00827002448483Motion Hybrid Wire GuideMHW-0381502021-09-09
00827002448490Motion Hybrid Wire GuideMHWA-0381502021-09-09
00827002448551Motion Hybrid Wire GuideMHWA-0351502021-09-09
08714729892038NovaGold5200M005520002016-09-21
08714729892045NovaGold5201M005520102016-09-21
00857834006070ERCPGI1012016-09-21
00857834006087ERCPGI1022016-09-21
00857834006094ERCPGI1032016-09-21
00857834006100ERCPGI1042016-09-21
00857834006117ERCPGI1052016-09-21
00857834006124ERCPGI1062016-09-21
00857834006131ERCPGI1072016-09-21
00857834006148ERCPGI1082016-09-21
00857834006155ERCPGI1092016-09-21
00857834006162ERCPGI1102016-09-21
00857834006179ERCPGI1112016-09-21
00857834006186ERCPGI1122016-09-21
00857834006193ERCPGI1132016-09-21
00857834006209ERCPGI1142016-09-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
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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
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193251ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193268ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193275ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902222357ARROWTELEFLEX INCORPORATEDDQX2026-07-27
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07