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Company Name Brand Name GMDN Term FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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E-Z LINK - 10614559104460

E-Z LINK
MEGADYNE MEDICAL PRODUCTS, INC.
MGEZLINK01
In Commercial Distribution

  • 10614559104460 ()


  • Surgical plume evacuation system

Mini Vac - 10614559104439

Mini Vac Surgical Smoke Evacuator 220v
MEGADYNE MEDICAL PRODUCTS, INC.
ECVV220
In Commercial Distribution

  • 10614559104439 ()


  • Surgical plume evacuation system

Mini Vac - 10614559104422

Mini Vac Surgical Smoke Evacuator 120v
MEGADYNE MEDICAL PRODUCTS, INC.
ECVV120
In Commercial Distribution

  • 10614559104422 ()
  • 30614559104426 ()


  • Surgical plume evacuation system

Megadyne - 10614559102060

Connector, Smoke Evacuator to Tubing, 22mm I.D., non-sterile
MEGADYNE MEDICAL PRODUCTS, INC.
2155
In Commercial Distribution

  • 10614559102060 ()


  • Surgical plume evacuation system

CORE DYNAMICS - 10653405045663

Laparoscopic Smoke Eliminator
Conmed Corporation
CD3900
In Commercial Distribution

  • 20653405045660 ()
  • 10653405045663 ()
  • 00653405045666 ()
CD3900

  • Surgical plume evacuation system

NA - 10653405005179

CABLE/STRAIN REL. BLACK
Conmed Corporation
711-7760
In Commercial Distribution

  • 10653405005179 ()
711-7760

  • Surgical plume evacuation system

Bovie - 10607151065161

SMOKE EVACUATOR ARTICULATED, ARMSTAND WITH FASTENERS
BOVIE MEDICAL CORPORATION
SEAS
In Commercial Distribution

  • 10607151065161 ()
SEAS

  • Surgical plume evacuation system

Bovie - 10607151008496

BOVIE EZ LINK
BOVIE MEDICAL CORPORATION
SERS2
In Commercial Distribution

  • 10607151008496 ()
SERS2

  • Surgical plume evacuation system

Bovie - 10607151008304

SMOKE SHARK II 120V-220V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02-220
In Commercial Distribution

  • 10607151008304 ()
SE02-220

  • Surgical plume evacuation system

Bovie - 10607151008298

SMOKE SHARK II 120 V - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
SE02
In Commercial Distribution

  • 10607151008298 ()
SE02

  • Surgical plume evacuation system

Bovie - 10607151004801

PNEUMATIC FOOTSWITCH - SMOKE EVACUATOR
BOVIE MEDICAL CORPORATION
FSSEP
In Commercial Distribution

  • 10607151004801 ()
FSSEP

  • Surgical plume evacuation system

MEGADYNE - 10614559104668

Megadyne Smoke Evacuator Connect Cable, 2.1m
MEGADYNE MEDICAL PRODUCTS, INC.
2406J
In Commercial Distribution

  • 10614559104668 ()


  • Surgical plume evacuation system

MEGADYNE - 10614559104651

Megadyne Smoke Evacuator Connect Cable, 1m
MEGADYNE MEDICAL PRODUCTS, INC.
2403J
In Commercial Distribution

  • 10614559104651 ()


  • Surgical plume evacuation system

MEGADYNE - 10614559104644

Megadyne Smoke Evacuator RF Sensor
MEGADYNE MEDICAL PRODUCTS, INC.
2255J
In Commercial Distribution

  • 10614559104644 ()


  • Surgical plume evacuation system

Origin 125º Short Neck Collared Hip Stem - 09348215024192

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1826
In Commercial Distribution

  • 09348215024192 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024185

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1626
In Commercial Distribution

  • 09348215024185 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024178

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1526
In Commercial Distribution

  • 09348215024178 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024161

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1426
In Commercial Distribution

  • 09348215024161 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024154

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1326
In Commercial Distribution

  • 09348215024154 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024147

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1226
In Commercial Distribution

  • 09348215024147 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024130

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1126
In Commercial Distribution

  • 09348215024130 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024123

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1026
In Commercial Distribution

  • 09348215024123 ()


  • Coated femoral stem prosthesis, modular

Origin 125º Short Neck Collared Hip Stem - 09348215024116

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0926
In Commercial Distribution

  • 09348215024116 ()


  • Coated femoral stem prosthesis, modular

Gmate® Origin Blood Glucose Monitoring System - 08809301160206

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use

Gmate® Origin Blood Glucose Monitoring System - 08809301160145

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use

Gmate® Origin Blood Glucose Monitoring System - 08809301160077

No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use

microTargeting™ Electrode and Insertion Tube Kit - 10873263001346

microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame and STar Drive. Contains: IT(AR16): Insertion Tube. IT(AR17): Insertion Tube w/ Stylet. MTDWLN(AR)(AR2): microTargeting Electrode. 66-CN-ET: Insertion Tube Extractor. Individual Specifications: IT(AR16) - 135mm tube length, 1.981mm OD, 0.96mm ID. IT(AR17) - 243.5mm tube length, 0.902mm OD, 0.597mm ID, 264mm stylet length (includes collar). MTDWLN(AR)(AR2) - 276.5mm electrode length, 10mm differential, 261.5mm protective tube length, 0.55mm OD. DZAP(L) 1 Meg
FHC, INC.
KTF1002-00134
In Commercial Distribution

  • 10873263001346 ()
  • 00873263001349 ()
KTF1002

  • Intracerebral cannula, implantable
  • Depth electrode

microTargeting™ Electrode and Insertion Tube Kit - 10873263001322

Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od
FHC, INC.
FC7100-00132
In Commercial Distribution

  • 10873263001322 ()
  • 00873263001325 ()
FC7100

  • Intracerebral cannula, implantable
  • Depth electrode

microTargeting™ Electrode and Insertion Tube Kit - 10873263001162

microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id
FHC, INC.
FC4001-00116
In Commercial Distribution

  • 10873263001162 ()
  • 00873263001165 ()
FC4001

  • Depth electrode
  • Intracerebral cannula, implantable

microTargeting™ Electrode and Insertion Tube - 10873263001155

microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id.
FHC, INC.
FC4000-00115
In Commercial Distribution

  • 10873263001155 ()
  • 00873263001158 ()
FC4000

  • Depth electrode
  • Intracerebral cannula, implantable

Titan - 00817914024905

Iris Straight Bipolar Forcep 3 1/2" (88.9mm) Insulated With A (High Polished 10mm Long Area) With A 0.5mm Tip Country Of Origin USA
TITAN MANUFACTURING INC
160818205030101
In Commercial Distribution

  • 00817914024905 ()


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

microTargeting™ Electrode and Insertion Tube Kit - 10873263007584

microTargeting STar Array Electrode and Insertion Tube Kit, 5x, for use with Stereotactic Frame and STar Drive. Contains: IT(AR16): Insertion Tube. IT(AR17): Insertion Tube w/ Stylet. MTDWLN(AR)(AR2): microTargeting Electrode. 66-CN-ET: Insertion Tube Extractor. Individual Specifications: IT(AR16) - 135mm tube length, 1.981mm OD, 0.96mm ID. IT(AR17) - 243.5mm tube length, 0.902mm OD, 0.597mm ID, 264mm stylet length (includes collar). MTDWLN(AR)(AR2) - 276.5mm electrode length, 10mm differential, 261.5mm protective tube length, 0.55mm OD. DZAP(L) 1 Meg
FHC, INC.
KTF1002-00758
In Commercial Distribution

  • 10873263007584 ()
  • 00873263007587 ()
KTF1002

  • Intracerebral cannula, nonimplantable, single-use
  • Depth electrode

microTargeting™ Electrode and Insertion Tube Kit - 10873263007560

Array Insertion Electrode/Tube with Stylet Kit, 5x, Sterile, for use with Nexframe and microTargeting Drive. Contains: IT(AR8): Insertion Tube w/ Stylet. MTDPBN(PA)(DB2): microTargeting Electrode. Individual Specifications: IT(AR8) - 217mm tube length, 0.89mm OD, 0.58mm ID MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm differential length, 234.2mm protective tube length. 1 Meg RZAP, 0.56mm od
FHC, INC.
FC7100-00756
In Commercial Distribution

  • 10873263007560 ()
  • 00873263007563 ()
FC7100

  • Depth electrode
  • Intracerebral cannula, nonimplantable, single-use

microTargeting™ Electrode and Insertion Tube Kit - 10873263007546

microTargeting D.ZAP Electrode Kit, 5x, Sterile, Single, 1 Meg, for use with NexFrame and NexDrive or mT Drive. Each box contains: 2x MTDPLN(PA)(DB2) D.ZAP Differential Electrode. 1x IT(DB3) Insertion tube with Stylet. 1x PT(DB5) Protective Tube. Individual Specifications: MTDPLN(PA)(DB2) - 249.2mm electrode length, 10mm tip exposure, 234.2mm protective tube length, .56mm od, 1.0 meg DZAP(L) IT(DB3) - 194mm length, 1.8mm od, 1.6mm id, PT(DB5) - 194mm length, 1.47mm od, 0.99mm id
FHC, INC.
FC4001-00754
In Commercial Distribution

  • 10873263007546 ()
  • 00873263007549 ()
FC4001

  • Depth electrode
  • Intracerebral cannula, nonimplantable, single-use

microTargeting™ Electrode and Insertion Tube - 10873263007539

microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id.
FHC, INC.
FC4000-00753
In Commercial Distribution

  • 10873263007539 ()
  • 00873263007532 ()
FC4000

  • Intracerebral cannula, nonimplantable, single-use
  • Depth electrode

Titan - 00817914024882

Yasargil Bayonet Bipolar Forcep 7 7/8" (200.03mm) Insulated With A (High Polished 10mm Long Area) With A 1.3mm Tip Anti-Stick Country of Origin: USA
TITAN MANUFACTURING INC
163128240070101
In Commercial Distribution

  • 00817914024882 ()

  • Length: 200.03 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

MediMax Tech - 00817325023740

SPSTI-SL-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Swivel Type, Button, Holster, Insulated Blade, 5 meter Hose
MEDIMAX TECH INC.
SPSTI-SL5
In Commercial Distribution

  • 20817325023744 ()
  • 10817325023747 ()
  • 00817325023740 ()
  • 40817325023748 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

MediMax Tech - 00817325023733

SPSTI-SL -EvaQMaxPen, Smoke Pencil, Telescopic, Swivel Type, Button, Holster, Insulated Blade, 3 meter Hose
MEDIMAX TECH INC.
SPSTI-SL
In Commercial Distribution

  • 20817325023737 ()
  • 10817325023730 ()
  • 00817325023733 ()
  • 30817325023734 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediMax Tech - 00817325023726

SPST-SL-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Swivel type, Button, Holster, Non-Stick Blade, 5 meter Hose
MEDIMAX TECH INC.
SPST-SL5
In Commercial Distribution

  • 20817325023720 ()
  • 10817325023723 ()
  • 00817325023726 ()
  • 30817325023727 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

MediMax Tech - 00817325023719

SPST-SL - EvaQMaxPen, Smoke Pencil, Telescopic, Swivel Type, Button, Holster, Non-Stick Blade, 3 Meter (10') hose
MEDIMAX TECH INC.
SPST-SL
In Commercial Distribution

  • 20817325023713 ()
  • 10817325023716 ()
  • 00817325023719 ()
  • 30817325023710 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediMax Tech - 00817325023702

SPECI-SL-5 - EvaQMaxPen, Smoke Pencil, Eco, Swivel Type, Button, Holster, Insulated Blade, 5 meter Hose
MEDIMAX TECH INC.
SPECI-SL5
In Commercial Distribution

  • 20817325023706 ()
  • 10817325023709 ()
  • 00817325023702 ()
  • 30817325023703 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

MediMax Tech - 00817325023696

SPECI-SL - EvaQMaxPen, Smoke Pencil, Eco, Swivel Type, Button, Holster, Insulated Blade, 3 meter Hose
MEDIMAX TECH INC.
SPECI-SL
In Commercial Distribution

  • 20817325023690 ()
  • 10817325023693 ()
  • 00817325023696 ()
  • 30817325023697 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediMax Tech - 00817325023689

SPEC-SL-5 - EvaQMaxPen, Smoke Pencil, Eco, Swivel Type, Button, Holster, Non-Stick Blade, 5 meter Hose
MEDIMAX TECH INC.
SPEC-SL5
In Commercial Distribution

  • 20817325023683 ()
  • 10817325023686 ()
  • 00817325023689 ()
  • 30817325023680 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

MediMax Tech - 00817325023665

SPEC-SL - EvaQMaxPen, Smoke Pencil, Eco, Swivel Type, Button, Holster, Non-Stick Blade,3 meter Hose
MEDIMAX TECH INC.
SPEC-SL
In Commercial Distribution

  • 20817325023669 ()
  • 10817325023662 ()
  • 00817325023665 ()
  • 30817325023666 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediMax Tech - 00817325023658

SPDEI-SL-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Swivel Type, Button, Holster, Insulated Blade, 5 Meter hose
MEDIMAX TECH INC.
SPDEI-SL5
In Commercial Distribution

  • 20817325023652 ()
  • 10817325023655 ()
  • 00817325023658 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

MediMax Tech - 00817325023641

SPDEI-SL - EvaQMaxPen, Smoke Pencil, Double Extension, Swivel Type, Button, Holster, Insulated Blade, 3 Meter hose
MEDIMAX TECH INC.
SPDEI-SL
In Commercial Distribution

  • 20817325023645 ()
  • 10817325023648 ()
  • 00817325023641 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediMax Tech - 00817325023634

SPDE-SL-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Swivel Type, Button, Holster, Non-Stick Blade, 5 Meter hose
MEDIMAX TECH INC.
SPDE-SL5
In Commercial Distribution

  • 20817325023638 ()
  • 10817325023631 ()
  • 00817325023634 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

MediMax Tech - 00817325023627

SPDE-SL -EvaQMaxPen, Smoke Pencil, Double Extension, Swivel Type, Button, Holster, Non-Stick Blade, 3 Meter (10') hose
MEDIMAX TECH INC.
SPDE-SL
In Commercial Distribution

  • 20817325023621 ()
  • 10817325023624 ()
  • 00817325023627 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system

MediMax Tech - 00817325023528

SPECI - EvaQMaxPen, Smoke Pencil, Eco pencil, Button, Holster, Insulated Blade, 3 Meter Hose- Each
MEDIMAX TECH INC.
SPECI
In Commercial Distribution

  • 20817325023522 ()
  • 10817325023525 ()
  • 00817325023528 ()
  • 30817325023529 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

MediMax Tech - 00817325023511

SPECI-5 - EvaQMaxPen, Smoke Pencil, Eco, Button, Holster, Insulated Blade, 5 meter Hose- Each
MEDIMAX TECH INC.
SPECI-5
In Commercial Distribution

  • 20817325023515 ()
  • 10817325023518 ()
  • 00817325023511 ()
  • 30817325023512 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
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