Company Name Brand Name GMDN Term Name GMDN Term Status 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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EvBN Push Button ESU Pencil - 2.5'' Stainless & Coated Blade, No Holster, ESU Pencil, 10'' Cable
MEDIMAX TECH INC.
EvBN Push Button ESU Pencil
In Commercial Distribution

  • 20817325020743 ()
  • 10817325020746 ()
  • 00817325020749 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvB Push Button ESU Pencil - 2.5'' Stainless Blade, No Holster, Smoke Pencil, 10'' Cable
MEDIMAX TECH INC.
EvB Push Button ESU Pencil
In Commercial Distribution

  • 20817325020736 ()
  • 10817325020739 ()
  • 00817325020732 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
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
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
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
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
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
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
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
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
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
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
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
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
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
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
SPEC-5 - EvaQMaxPen, Smoke Pencil, Eco, Button, Holster, Non-Stick Blade, 5 meter Hose- Each
MEDIMAX TECH INC.
SPEC-5
In Commercial Distribution

  • 20817325023508 ()
  • 10817325023501 ()
  • 00817325023504 ()
  • 30817325023505 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EvaQMaxPen, Smoke Pencil, Eco, Button, Holster, Non-Stick Blade, 3 Meter Hose - Each
MEDIMAX TECH INC.
SPEC
In Commercial Distribution

  • 00817325023498 ()
  • 10817325023495 ()
  • 20817325023492 ()
  • 30817325023499 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPDEI-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Insulated Blade, 5 Meter hose - Each
MEDIMAX TECH INC.
SPDEI-5
In Commercial Distribution

  • 20817325023485 ()
  • 10817325023488 ()
  • 00817325023481 ()
  • 30817325023482 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPDEI - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Insulated Blade, 3 Meter Hose - Each/ elbow type
MEDIMAX TECH INC.
SPDEI
In Commercial Distribution

  • 20817325023478 ()
  • 10817325023471 ()
  • 00817325023474 ()
  • 30817325023475 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPDE-5 - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Non-Stick Blade, 5 Meter hose - Each
MEDIMAX TECH INC.
SPDE-5
In Commercial Distribution

  • 20817325023461 ()
  • 10817325023464 ()
  • 00817325023467 ()
  • 30817325023468 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPDE - EvaQMaxPen, Smoke Pencil, Double Extension, Button, Holster, Non-Stick Blade, 3 Meter (10') Hose - elbow type
MEDIMAX TECH INC.
SPDE
In Commercial Distribution

  • 20817325023454 ()
  • 10817325023457 ()
  • 00817325023450 ()
  • 40817325023458 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPSTI-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Insulated Blade, 5 meter Hose- Each, elbow type
MEDIMAX TECH INC.
SPSTI-5
In Commercial Distribution

  • 10817325023440 ()
  • 00817325023443 ()
  • 20817325023447 ()
  • 30817325023444 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPSTI - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Insulated Blade, 3 Meter Hose - Each; elbow type
MEDIMAX TECH INC.
SPSTI
In Commercial Distribution

  • 20817325023430 ()
  • 10817325023433 ()
  • 00817325023436 ()
  • 30817325023437 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPST-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Non-Stick Blade, 5 meter Hose - Each ; elbow type
MEDIMAX TECH INC.
SPST-5
In Commercial Distribution

  • 20817325023423 ()
  • 10817325023426 ()
  • 00817325023429 ()
  • 30817325023420 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPST - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Non-Stick Blade, 3 Meter (10') Hose ; Elbow type
MEDIMAX TECH INC.
SPST
In Commercial Distribution

  • 20817325023416 ()
  • 10817325023419 ()
  • 00817325023412 ()
  • 30817325023413 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNHDE- Double extension, telescopic, Smoke Evacuation Pencil with non-stick electrode and holster 1 pc per pack/ 10 pcs per box/ 8 boxes per case.
MEDIMAX TECH INC.
EvBNHDE- Double extension, telescopic, Smoke Evacuation Pencil with Non-Stick
In Commercial Distribution

  • 20817325023409 ()
  • 10817325023402 ()
  • 00817325023405 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EcoEvRNHT-15 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvRNHT-15
In Commercial Distribution

  • 20817325023089 ()
  • 10817325023082 ()
  • 00817325023085 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvRNHT-10 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvRNHT-10
In Commercial Distribution

  • 20817325023072 ()
  • 10817325023075 ()
  • 00817325023078 ()


  • Surgical plume evacuation system
  • Electrosurgical return electrode, single-use
EcoEvRNH-15 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvRNH-15
In Commercial Distribution

  • 20817325023065 ()
  • 10817325023068 ()
  • 00817325023061 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster
MEDIMAX TECH INC.
EcoEvRNH-10
In Commercial Distribution

  • 20817325023058 ()
  • 10817325023051 ()
  • 00817325023054 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvBNHT-15 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvBNHT-15
In Commercial Distribution

  • 20817325023041 ()
  • 10817325023044 ()
  • 00817325023047 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvBNHT-10 Standard Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvBNHT-10
In Commercial Distribution

  • 20817325023034 ()
  • 10817325023037 ()
  • 00817325023030 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvBNH-15 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvBNH-15
In Commercial Distribution

  • 20817325023027 ()
  • 10817325023020 ()
  • 00817325023023 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EcoEvBNH-10 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvBNH-10
In Commercial Distribution

  • 20817325023010 ()
  • 10817325023013 ()
  • 00817325023016 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNHT-15 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EvBNHT-15
In Commercial Distribution

  • 20817325023003 ()
  • 10817325023006 ()
  • 00817325023009 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNHT-10 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EvBNHT-10
In Commercial Distribution

  • 20817325022990 ()
  • 10817325022993 ()
  • 00817325022996 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH-15 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EvBNH-15
In Commercial Distribution

  • 20817325022983 ()
  • 10817325022986 ()
  • 00817325022989 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH-10 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EvBNH-10
In Commercial Distribution

  • 20817325022976 ()
  • 10817325022979 ()
  • 00817325022972 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EXTLI-5 : Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
EXTLI-5
In Commercial Distribution

  • 10850034735112 ()
  • 00850034735115 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EXTL-5 : Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
EXTL-5
In Commercial Distribution

  • 10850034735105 ()
  • 00850034735108 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EXTLI - Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
EXTLI
In Commercial Distribution

  • 10850034735099 ()
  • 00850034735092 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EXTL - Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
EXTL
In Commercial Distribution

  • 10850034735082 ()
  • 00850034735085 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
REGL-5 : Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
REGL-5
In Commercial Distribution

  • 10850034735075 ()
  • 00850034735078 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
REGLI-5 : Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
REGLI-5
In Commercial Distribution

  • 10850034735068 ()
  • 00850034735061 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
REGLI - Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
REGLI
In Commercial Distribution

  • 10850034735051 ()
  • 00850034735054 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
REGL - Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
REGL
In Commercial Distribution

  • 10850034735044 ()
  • 00850034735047 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
microTargeting Frame Kit D.ZAP/Lead Insertion, 1x, Sterile, for use with mT Drive or STar Drive. Contains: 34685L: Single D.ZAP Electrode. 66-DA-SD: Drape Sleeve. 66-EL-LP: Patient Lead for LP+. 66-IT-05P: Single Insertion Tube Set.
FHC, INC.
KT-FPK-S20-00508
In Commercial Distribution

  • 00873263005088 ()
KT-FPK-S20

  • Depth electrode
  • Neurological stereotactic surgery system
  • Intracerebral cannula, implantable
microTargeting Platform Procedure Consumables Kit, 1x, sterile, for use with mT or STar Drive, mT Platform and Guideline 4000 LP+. Contains: 44975L: D.ZAP Tungsten Differential Electrode - - 220.72mm electrode length, 10mm differential, 205.72mm protective tube length, DZAP(L) 1Meg, 0.55mm od. 66-DA-SD: Sterile Drape Sleeve for motor 66-EL-LP: Patient Lead for Guideline 4000 LP+ 66-IT-03P: Sterile Single Insertion Tube Set - IT(MP1) - 184.1mm tube length, 1.83mm od, 1.6mm id with Stylet PT(MP1) - Diameter reduction tube 0.58mm id
FHC, INC.
KT-PPK-S-00366
In Commercial Distribution

  • 00873263003664 ()
KT-PPK-S

  • Depth electrode
  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable
microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm
FHC, INC.
KTF1001-00133
Not in Commercial Distribution

  • 00873263001332 ()
KTF1001

  • Patient surgical drape, single-use
  • Intracerebral cannula, implantable
  • Depth electrode
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