FDA.reportPublic FDA data

NAMIC

Primary DI
H749804850030
Brand
NAMIC
Company
NAVILYST MEDICAL, INC.
Model
80485003
Device description
TD2 Torque Device
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWIRE, GUIDE, CATHETER
PTLWire, guide, catheter, exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
PTLWire, Guide, Catheter, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H749804850031PackageHIBCC1000In Commercial Distribution
H749804850030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Torque manipulation deviceA 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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
809699023
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787LG191005LifeguardLG-19-1002016-09-20
H787LG19755LifeguardLG-19-752016-09-20
H787LG201005LifeguardLG-20-1002016-09-20
H787LG201505LifeguardLG-20-1502016-09-20
H787LG20505LifeguardLG-20-502016-09-20
H787LG20755LifeguardLG-20-752016-09-20
H787LG221005LifeguardLG-22-1002016-09-20
H787LG22505LifeguardLG-22-502016-09-20
H787LG22755LifeguardLG-22-752016-09-20
H787LPS30045LifeportLPS 30042016-09-20
H787LPS30055LifeportLPS 30052016-09-20
H787LPS30065LifeportLPS 30062016-09-20
H787LPS30075LifeportLPS 30072016-09-20
H787LPS30085LifeportLPS 30082016-09-20
H787LPS30095LifeportLPS 30092016-09-20
H787LPS30175LifeportLPS 30172016-09-20
H787LPS30235LifeportLPS 30232016-09-20
H787LPS30255LifeportLPS 30252016-09-20
H787CT50LPBANFVI0BioFlo VortexCT50LPBANFVI2020-05-29
H787CT50LPBAVI0BioFlo VortexCT50LPBAVI2020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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