FDA.reportPublic FDA data

Hi-Torque Connect

Primary DI
00816349014888
Brand
Hi-Torque Connect
Company
BRIVANT LIMITED
Model
1012587
Device description
Hi-Torque Connect, 0.018”, 145cm, 4g, Straight
Published
2026-04-24
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
10816349014885PackageGS15In Commercial Distribution
00816349014888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081634901488510816349014885
00816349014888008163490148888163490148880816349014888

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
00816349014895Hi-Torque Connect10125882026-04-24
00816349014901Hi-Torque Connect10125892026-04-24
00816349014918Hi-Torque Connect10125902026-04-27
00816349014925Hi-Torque Connect10125912026-04-27
00816349014932Hi-Torque Connect10125922026-04-27
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
00816349011610ExcursionEXCSN,FPY,NOR,S,HY,FLT 195-0101621-000-0102017-11-08
00816349010439Hydraview HVIEW GW, ES, S 190-014901021-012017-05-23
00816349010446Hydraview HVIEW GW, DS, S 190-014901021-022017-05-23
00816349010453Hydraview HVIEW GW, EDS, S TIP 190-014901021-032017-05-23
00816349010460Hydraview HVIEW GW, ES-J, J-TIP 190-014901021-042017-05-23
00816349010477Hydraview HVIEW GW, DS-J, J 190-014901021-052017-05-23
00816349010484Hydraview HVIEW GW, EDS-J, J 190-014901021-062017-05-23
00816349010880Flagship FSHP FLPY, XSUP, S, HY 195-0141601-100-011 2017-05-05
00816349010910Flagship FSHP, FLPY, NOR, S, HY 300-0141601-010-011 2017-04-21
00816349010927Flagship SB FSHP SB GPS,FLPY,J4,HY 195-0141701-004-010 2017-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
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