FDA.reportPublic FDA data

Torque manipulation device

Definition
A sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.
GUDID devices
109
Last updated
2026-10-06 03:49:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B0905XGW0SPINRZien Medical Technologies, LLC5X-GW2022-07-21
B090SPN10050SPINRZien Medical Technologies, LLCSPN-10052023-05-03
07613327006070ARIAStryker Corporation487557012019-10-14
07613327096217ES2 SPINAL SYSTEMStryker Corporation482801842019-10-14
07613327264760XIA 4.5Stryker Corporation481370562019-10-14
07613327265545XIA 3Stryker Corporation482370562019-10-14
07613327266825MANTISStryker Corporation482840802019-10-14
07613327271690OASYSStryker Corporation485620272019-10-14
07613327275643XIA ELEGANCEStryker Corporation4823970262019-10-14
07613327480115Xia 3Stryker CorporationIS4498XLP2019-05-30
07613327506983Xia 3Stryker CorporationIS4548XLP2020-08-07
10888857550179YUKON OCT Spinal SystemVB Spine LLCPRO-11842022-02-15
10888857554368K2M General InstrumentsVB Spine LLCPRO-1205-012022-08-03
10888857554375K2M General InstrumentsVB Spine LLCPRO-1205-022022-08-03
10888857554382K2M General InstrumentsVB Spine LLCPRO-1205-032022-08-03
10888857563117EVEREST Spinal SystemVB Spine LLCPRO-13412023-07-27
00884450456231Merit Medical®Merit Medical Systems, Inc.A2026-09-04
10193489078022NAMICMEDLINE INDUSTRIES, INC.H749044872022022-02-24
30193489067044NAMICMEDLINE INDUSTRIES, INC.804850032021-06-03
00643169002968NAMEDTRONIC, INC.AC40062016-10-02
00643169843066NAMEDTRONIC, INC.0089582018-07-06
00643169843103NAMEDTRONIC, INC.AC40062018-07-06
00763000185817Kendall™Covidien LPWWTD350012020-10-25
00763000919641Kendall™EV3, INCWWTD350012024-06-01
00813132020446TorqMax Sheath Grip AccessorySpectranetics Corporation502-0012015-02-06
00827002583412CookCook Vandergrift Inc.G583412023-11-16
00884450008058Seadragon™Merit Medical Systems, Inc.008844500080582016-10-10
00884450277225SPINR™Merit Medical Systems, Inc.008844502772252016-09-24
00884450277249SPINR™Merit Medical Systems, Inc.008844502772492016-09-24
00884450458068SeaDragon2™Merit Medical Systems, Inc.008844504580682020-08-14
00884450834268SPINR™Merit Medical Systems, Inc.B2025-02-05
00886333222100Guidewire Torque HandleARGON MEDICAL DEVICES, INC.E3870012016-09-20
05415067046512NAST. JUDE MEDICAL, INC.A001HELX2023-01-31
08714729741404NABOSTON SCIENTIFIC CORPORATIONM0014655002016-09-24
08717648013294TORQUE DEVICEABBOTT VASCULAR INC.222152016-08-05
08717648013928TORQUE DEVICEABBOTT VASCULAR INC.10032792016-08-05
10193489078015NAMICMEDLINE INDUSTRIES, INC.H749024700122021-07-26
10841156101329VSZLTELEFLEX INCORPORATEDIPN9141782018-11-08
20193489067146NAMICMEDLINE INDUSTRIES, INC.805194122021-05-12
20193489068006NAMICMEDLINE INDUSTRIES, INC.814003002021-05-12
34987350774638RADIFOCUS TORQUE DEVICETERUMO CORPORATIONTD012016-09-09
36927675513480RADIFOCUSTerumo Medical Products (Hangzhou) Co., Ltd.XX*RF02AH2022-12-08
H74902470010NAMICNAVILYST MEDICAL, INC.02470012016-09-20
H74904487200NAMICNAVILYST MEDICAL, INC.04487202016-09-20
H749804850030NAMICNAVILYST MEDICAL, INC.804850032015-09-17
H965805194120NAMICNAVILYST MEDICAL, INC.805194122015-09-17
H965814003000NAMICNAVILYST MEDICAL, INC.814003002015-09-17
M2045020010TorqMax™Spectranetics Corporation502-0012014-08-19
00810024671724DF4 Helix Locking ToolCENTERPOINT SYSTEMS LLCA002HELX2025-12-03
00643169265691NAMEDTRONIC, INC.6056M2025-11-29
08714729035886NABOSTON SCIENTIFIC CORPORATIONM0014655002016-09-24
10884450834265SPINR™Merit Medical Systems, Inc.B2025-02-05
20763000919645Kendall™EV3, INCWWTD350012024-06-01
00810024670291Helix Locking ToolCENTERPOINT SYSTEMS LLC56162024-03-15
00763000812072NAMEDTRONIC, INC.60562024-03-11
56927675513484RADIFOCUSTerumo Medical Products (Hangzhou) Co., Ltd.XX*RF02AH2022-12-08
10827002583419CookCook Vandergrift Inc.G583412023-11-16
00763000562793NAMEDTRONIC, INC.6056M2023-11-10
B090SPN10051SPINRZIEN MEDICAL TECHNOLOGIES, INC.SPN-10052023-05-03
06936775511486Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-1-52023-04-18
06936775511493Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-1-82023-04-18
06936775511509Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-1-102023-04-18
06936775511516Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-1-122023-04-18
06936775511523Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-2-52023-04-18
06936775511530Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-2-82023-04-18
06936775511547Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-2-102023-04-18
06936775511554Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-2-122023-04-18
06936775511561Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-3-82023-04-18
06936775511578Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-3-102023-04-18
06936775511585Torque Device for GuidewireAmsinomed Medical Co.,LtdMZCH-3-122023-04-18
B0905XGW1SPINRZIEN MEDICAL TECHNOLOGIES, INC.5X-GW2022-07-21
20193489078029NAMICMEDLINE INDUSTRIES, INC.H749044872022022-02-24
06947358544302Sunmed guidewire torque deviceSunny Medical Device (Shenzhen) Co., Ltd.plastic type, white2022-01-04
M2045020011TorqMax™Spectranetics Corporation502-0012014-08-19
20193489078012NAMICMEDLINE INDUSTRIES, INC.H749024700122021-07-26
10193489067040NAMICMEDLINE INDUSTRIES, INC.804850032021-06-03
10193489067149NAMICMEDLINE INDUSTRIES, INC.805194122021-05-12
10193489068009NAMICMEDLINE INDUSTRIES, INC.814003002021-05-12
20763000185811Kendall™Covidien LPWWTD350012020-10-25
00827002034686CookCOOK INCORPORATEDG034682020-10-02