FDA.reportPublic FDA data

Hi-Torque Connect

Primary DI
00816349014932
Brand
Hi-Torque Connect
Company
BRIVANT LIMITED
Model
1012592
Device description
Hi-Torque Connect Flex, 0.018”, 300cm, 12g, Straight
Published
2026-04-27
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

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
10816349014939PackageGS15In Commercial Distribution
00816349014932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081634901493910816349014939
00816349014932008163490149328163490149320816349014932

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.

Regulatory Flags#

DUNS number
985303473
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
00816349014994CPS Courier GuidewireDS2G0042026-06-26
00816349015007CPS Courier GuidewireDS2G0092026-06-26
00816349015014CPS Courier GuidewireDS2G0032026-06-26
00816349015021CPS Courier GuidewireDS2G0082026-06-26
00816349015038CPS Courier GuidewireDS2G0022026-06-26
00816349015045CPS Courier GuidewireDS2G0072026-06-26
00816349015052CPS Courier GuidewireDS2G0012026-06-26
00816349015069CPS Courier GuidewireDS2G0062026-06-26
00816349015076CPS Courier GuidewireDS2G0002026-06-26
00816349015083CPS Courier GuidewireDS2G0052026-06-26
00816349014888Hi-Torque Connect10125872026-04-24
00816349014895Hi-Torque Connect10125882026-04-24
00816349014901Hi-Torque Connect10125892026-04-24
00816349014918Hi-Torque Connect10125902026-04-27
00816349014925Hi-Torque Connect10125912026-04-27
00816349014949Hi-Torque Connect10125932026-04-27
00816349014956Hi-Torque Connect10125942026-04-27
00816349014963Hi-Torque Connect10125952026-04-27
00816349011597ExcursionEXCSN,MED,NOR,S,HY,FLT 195-0101622-000-0102017-11-08
00816349011603ExcursionEXCSN,STD,NOR,J,HY,FLT 195-0101623-001-0102017-11-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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