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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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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 - 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 - 09348215024123

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

  • 09348215024123 ()


  • 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 - 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

EVO Cable Assembly - 00856895008375

EVO Cable Assembly Only
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
EVO Cable Assembly
In Commercial Distribution

  • 00856895008375 ()
NEC1602

  • Cortical electrode
  • Depth electrode

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

MediMax Tech - 00817325023504

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

MediMax Tech - 00817325023498

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

MediMax Tech - 00817325023481

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

MediMax Tech - 00817325023474

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

MediMax Tech - 00817325023467

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

MediMax Tech - 00817325023450

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

MediMax Tech - 00817325023443

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

MediMax Tech - 00817325023436

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

MediMax Tech - 00817325023429

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

MediMax Tech - 00817325023412

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

MediMax Tech - 00817325023405

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

MediMax Tech - 00817325023085

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

MediMax Tech - 00817325023078

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

MediMax Tech - 00817325023061

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

MediMax Tech - 00817325023054

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
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