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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Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003139 ()
203511-55

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003122 ()
203511-50

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003115 ()
203511-45

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003108 ()
203511-40

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003092 ()
203511-35

  • Intraurethral valve/pump
Intraurethral Valve-Pump
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003085 ()
203511-30

  • Intraurethral valve/pump
Urethral measurement device, female.
VESIFLO INC
March 2017
In Commercial Distribution

  • 00862563003078 ()
203511-SD

  • Intraurethral valve/pump
No Description
Hertart ApS
16106
In Commercial Distribution

  • 27350025914606 ()
  • 17350025914609 ()
  • 07350025914602 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16105
In Commercial Distribution

  • 27350025914590 ()
  • 17350025914593 ()
  • 07350025914596 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16103
In Commercial Distribution

  • 17350025914579 ()
  • 27350025914576 ()
  • 07350025914572 ()


  • Assisted reproduction centrifuge tube
No Description
Hertart ApS
16101
In Commercial Distribution

  • 07350025914558 ()
  • 17350025914555 ()
  • 27350025914552 ()


  • Assisted reproduction centrifuge tube
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-015722
In Commercial Distribution

  • 50749756248117 ()
  • 00749756248112 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000703
In Commercial Distribution

  • 50749756237487 ()
  • 00749756237482 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000723
In Commercial Distribution

  • 50749756236008 ()
  • 00749756236003 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil and Holster
DEROYAL INDUSTRIES, INC.
88-00M702
In Commercial Distribution

  • 50749756231201 ()
  • 00749756231206 ()


  • Surgical plume evacuation system
Laparoscopic Smoke Tube Connector
DEROYAL INDUSTRIES, INC.
88-000695
In Commercial Distribution

  • 50749756231171 ()
  • 00749756231176 ()


  • Surgical plume evacuation system
Evacuation Hose
DEROYAL INDUSTRIES, INC.
88-003540
In Commercial Distribution

  • 50749756157976 ()
  • 00749756157971 ()


  • Surgical plume evacuation system
Universal Smoke Evac Attachment
DEROYAL INDUSTRIES, INC.
88-003590
In Commercial Distribution

  • 50749756157969 ()
  • 00749756157964 ()


  • Surgical plume evacuation system
Electrosurgical Pencil, Coated Blade and Holster
DEROYAL INDUSTRIES, INC.
88-000621
In Commercial Distribution

  • 50749756157938 ()
  • 00749756157933 ()


  • Surgical plume evacuation system
Electrosurgical Pencil, Coated Blade and Holster
DEROYAL INDUSTRIES, INC.
88-000622
In Commercial Distribution

  • 50749756157921 ()
  • 00749756157926 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000722
In Commercial Distribution

  • 50749756157914 ()
  • 00749756157919 ()


  • Surgical plume evacuation system
Universal Smoke Evac Attachment
DEROYAL INDUSTRIES, INC.
88-000600
In Commercial Distribution

  • 50749756157884 ()
  • 00749756157889 ()


  • Surgical plume evacuation system
Electrosurgical Pencil and Holster
DEROYAL INDUSTRIES, INC.
88-000602
In Commercial Distribution

  • 50749756157860 ()
  • 00749756157865 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil and Holster
DEROYAL INDUSTRIES, INC.
88-000702
In Commercial Distribution

  • 50749756157853 ()
  • 00749756157858 ()


  • Surgical plume evacuation system
ExtendEVAC Electrosurgical Pencil
DEROYAL INDUSTRIES, INC.
88-000725
In Commercial Distribution

  • 50749756314768 ()
  • 00749756314763 ()


  • Surgical plume evacuation system
Smoke EVAC Wand
DEROYAL INDUSTRIES, INC.
88-000700
In Commercial Distribution

  • 50749756305650 ()
  • 00749756305655 ()


  • Surgical plume evacuation system
Smoke Attachment
Covidien LP
E3590
In Commercial Distribution

  • 20884524000296 ()
  • 10884524000299 ()


  • Surgical plume evacuation system
Laparoscopic Smoke Eliminator
Conmed Corporation
CD3900
Not in Commercial Distribution

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

  • Surgical plume evacuation system
EvaQMax Fit - FIT-5 w/ 16' Hose / Each
MEDIMAX TECH INC.
FIT-5
In Commercial Distribution

  • 20817325023591 ()
  • 10817325023594 ()
  • 00817325023597 ()
  • 30817325023598 ()


  • Surgical plume evacuation system
EvaQMax Fit - FIT 10' Hose / Each
MEDIMAX TECH INC.
FIT
In Commercial Distribution

  • 20817325023584 ()
  • 10817325023587 ()
  • 00817325023580 ()
  • 30817325023581 ()


  • Surgical plume evacuation system
EQM-U : EvaQMax Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit // Reusable
MEDIMAX TECH INC.
EvaQMax
In Commercial Distribution

  • 00817325023566 ()
EQM-U

  • Surgical plume evacuation system
Zip Pen Extension Nozzle 5.2" (13.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2560J
In Commercial Distribution

  • 10614559105757 ()
  • 50614559105755 ()
  • 30614559105751 ()
2560J

  • Surgical plume evacuation system
Tube Adapter
MEGADYNE MEDICAL PRODUCTS, INC.
2151J
In Commercial Distribution

  • 10614559105733 ()
  • 30614559105737 ()
2151J

  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Modified Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, E Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME725M1E
In Commercial Distribution

  • 10614559105672 ()
  • 30614559105676 ()
ME725M1E

  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Standard Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, E Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME7251E
In Commercial Distribution

  • 10614559105665 ()
  • 30614559105669 ()
ME7251E

  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Modified Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, C Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME725M1C
In Commercial Distribution

  • 10614559105658 ()
  • 30614559105652 ()
ME725M1C

  • Surgical plume evacuation system
MEGADYNE ACE BLADE 700, 2.5" Standard Blade, PTFE Coated, ZIP Pen Smoke Evacuation Pencil, C Connector, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
ME7251C
In Commercial Distribution

  • 10614559105641 ()
  • 30614559105645 ()
ME7251C

  • Surgical plume evacuation system
Zip Pen Extension Nozzle 2.7" (6.8 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2540J
In Commercial Distribution

  • 10614559105320 ()
  • 30614559105324 ()
  • 50614559105328 ()
2540J

  • Surgical plume evacuation system
Megadyne Smoke Evacuator RF Sensor
MEGADYNE MEDICAL PRODUCTS, INC.
2255J
In Commercial Distribution

  • 10614559104644 ()
  • 30614559104648 ()
  • 50614559104642 ()
2255J

  • Surgical plume evacuation system
Megadyne Speculum Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2395J
In Commercial Distribution

  • 10614559104606 ()
  • 30614559104600 ()
2395J

  • Surgical plume evacuation system
Megadyne Laparoscopic Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2390J
In Commercial Distribution

  • 10614559104590 ()
  • 30614559104594 ()
2390J

  • Surgical plume evacuation system
Mini Vac Surgical Smoke Evacuator 220v
MEGADYNE MEDICAL PRODUCTS, INC.
ECVV220
Not in Commercial Distribution

  • 10614559104439 ()


  • Surgical plume evacuation system
WELF-5 : WelFit Adaptor for ESU Pencils and Hyfrecators, 15' hose (1pc)
Medisourcenet, Inc
WELF-5
In Commercial Distribution

  • 10850034735136 ()
  • 00850034735139 ()


  • Surgical plume evacuation system
WELF - WelFit Adaptor for ESU Pencils and Hyfrecators, 10' hose (1pc)
Medisourcenet, Inc
WELF
In Commercial Distribution

  • 10850034735129 ()
  • 00850034735122 ()


  • Surgical plume evacuation system
Smoke Attachment Extender
Covidien LP
E3595
In Commercial Distribution

  • 10884524001814 ()
  • 20884524001811 ()


  • Surgical plume evacuation system
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
Not in Commercial Distribution

  • 10873263001346 ()
  • 00873263001349 ()
KTF1002

  • Intracerebral cannula, implantable
  • Depth electrode
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
Not in Commercial Distribution

  • 10873263001322 ()
  • 00873263001325 ()
FC7100

  • Intracerebral cannula, implantable
  • Depth electrode
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
Not in Commercial Distribution

  • 10873263001162 ()
  • 00873263001165 ()
FC4001

  • Depth electrode
  • Intracerebral cannula, implantable
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
Not in Commercial Distribution

  • 10873263001155 ()
  • 00873263001158 ()
FC4000

  • Depth electrode
  • Intracerebral cannula, implantable
54.5mm x 16 contact sEEG - RF Probe
NEUROONE MEDICAL TECHNOLOGIES CORPORATION
NSEEG5516-RF
In Commercial Distribution

  • 00856895008627 ()


  • Depth electrode
  • Percutaneous radio-frequency ablation probe, brain-ablation
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