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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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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

microTargeting™ Insertion Tube - 10873263004286

microTargeting MR Lead Insertion Tube with Ceramic Stylet, nonsterile
FHC, INC.
66-IT-MR1-00428
In Commercial Distribution

  • 10873263004286 ()
  • 00873263004289 ()

  • Length: 198.85 Millimeter
  • Outer Diameter: 1.8 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
66-IT-MR1

  • Intracerebral cannula, implantable

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
Not 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
Not in Commercial Distribution

  • 10873263001322 ()
  • 00873263001325 ()
FC7100

  • Intracerebral cannula, implantable
  • Depth electrode

microTargeting™ STar™ Insertion Tube Set - 10873263001230

microTargeting STar Drive Single Electrode Insertion Tube Set, 5x, Sterile, for use with Nexframe and STar Drive. Contains: IT(DB7): Insertion Tube with Stylet - 205.6mm length, 1.83mm OD, 1.6mm ID PT(DB7) Protective Tube - 1.50mm OD, 0.58mm ID
FHC, INC.
FC9003-00123
Not in Commercial Distribution

  • 10873263001230 ()
  • 00873263001233 ()
FC9003

  • Intracerebral cannula, implantable

microTargeting™ Insertion Tube - 10873263001223

microTargeting Array Lead Insertion Tube with Stylet, 5x, Sterile, for Nexframe and STarDrive
FHC, INC.
FC9002-00122
Not in Commercial Distribution

  • 10873263001223 ()
  • 00873263001226 ()

  • Length: 218.35 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
  • Outer Diameter: 1.83 Millimeter
FC9002

  • Intracerebral cannula, implantable

microTargeting™ STar™ Insertion Tube - 10873263001216

microTargeting STar Drive Array Electrode Insertion Tube with Stylet, 5x, Sterile, for use with Nexframe and STar Drive. Each Kit Contains: IT(AR22): Guide Tube - 1.83mm OD, 0.97mm ID (does not enter brain) IT(AR23): Insertion Tube w/ Stylet - 208mm length, 0.90mm OD, 0.60mm ID
FHC, INC.
FC9001-00121
Not in Commercial Distribution

  • 10873263001216 ()
  • 00873263001219 ()
FC9001

  • Intracerebral cannula, implantable

STar™ Drive Insertion Tube Extractor - 10873263001209

STar(TM) Drive Array Electrode Insertion Tube Extractor, 5x, Sterile, for use with STar(TM) Array Insertion Tubes
FHC, INC.
FC8011-00120
In Commercial Distribution

  • 10873263001209 ()
  • 00873263001202 ()
FC8011

  • Intracerebral cannula, implantable

microTargeting™ STar™ Insertion Tube - 10873263001193

microTargeting STar Drive Array Electrode Insertion Tube Set with Stylet, 5x, Sterile, for use with a Stereotactic Frame. Each Kit Contains: (1) IT(AR16) Insertion Tube Guide - 1.83mm OD, 0.96mm ID (does not enter brain) (1) IT(AR17) Insertion Tube w/ Stylet - 241.5mm tube length, 0.90mm tube OD, 0.60mm tube ID
FHC, INC.
FC8009-00119
Not in Commercial Distribution

  • 10873263001193 ()
  • 00873263001196 ()
FC8009

  • Intracerebral cannula, implantable

microTargeting™ Insertion Tube - 10873263001186

microTargeting Lead Insertion Tube with Stylet, 5x, Sterile, Array for use with NexFrame and mT Drive.
FHC, INC.
FC7140LI-00118
Not in Commercial Distribution

  • 10873263001186 ()
  • 00873263001189 ()

  • Length: 225.35 Millimeter
  • Outer Diameter: 1.83 Millimeter
  • Lumen/Inner Diameter: 1.6 Millimeter
FC7140LI

  • Intracerebral cannula, implantable

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
Not 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
Not in Commercial Distribution

  • 10873263001155 ()
  • 00873263001158 ()
FC4000

  • Depth electrode
  • Intracerebral cannula, implantable

microTargeting™ Insertion Tube Set - 10873263001148

microTargeting Single electrode insertion tube set, sterile, 5x, 20mm above target. Contains: IT(BP5): Insertion Tube & Stylet - 199mm length, 1.83mm OD, 1.60mm ID PT(BP5): Protective Tube - 201mm length, 1.47mm OD, 0.99mm ID
FHC, INC.
FC1036-00114
Not in Commercial Distribution

  • 10873263001148 ()
  • 00873263001141 ()
FC1036

  • Intracerebral cannula, implantable

microTargeting™ Insertion Tube - 10873263001131

microTargeting Array Lead Electrode Insertion Tube with Stylet, 5x, Sterile, for use with STar and MT Drive
FHC, INC.
FC1019-00113
Not in Commercial Distribution

  • 10873263001131 ()
  • 00873263001134 ()

  • Lumen/Inner Diameter: 1.6 Millimeter
  • Length: 243.5 Millimeter
  • Outer Diameter: 1.83 Millimeter
FC1019

  • Intracerebral cannula, implantable

microTargeting™ Insertion Tube - 10873263001124

microTargeting Array Electrode Insertion Tube with Stylet, Sterile, 5x for use with mT Drive Includes and one IT(AR1) and one IT(AR2). Individual Specifications: IT(AR1): Length=239.9mm, OD=0.88mm, ID=0.58mm IT(AR2): OD=1.83mm, ID=0.97mm (does not enter brain)
FHC, INC.
FC1018-00112
Not in Commercial Distribution

  • 10873263001124 ()
  • 00873263001127 ()
FC1018

  • Intracerebral cannula, implantable

TCD B40 Wafers - 10866305000278

The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000278 ()
  • 00866305000271 ()
480-B40-00-2038

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000254

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000254 ()
  • 00866305000257 ()
480-RW-2478-03

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000247

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000247 ()
  • 00866305000240 ()
480-RW-2478-02

  • Laboratory tubing welder

RapidWeld Blade Module Kit - 10866305000230

The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis RapidWeld STW, Model GRW-430 will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed.
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 10866305000230 ()
  • 00866305000233 ()
480-RW-2478-01

  • Laboratory tubing welder

TCD B40 Wafers - 10866305000223

The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 10866305000223 ()
  • 00866305000226 ()
480-B40-00-1274

  • Laboratory tubing welder

Safe-T-Surg - 10865082000167

Safe-T-Surg Retractor
BihlerMed, L.L.C.
2804-01-0001
In Commercial Distribution

  • 20865082000164 ()
  • 10865082000167 ()
  • 00865082000160 ()


  • Surgical retractor/retraction system blade, reusable

Scintillant - 10865082000136

Scintillant Surgical Light with Retractor
BihlerMed, L.L.C.
2658-01-0004
In Commercial Distribution

  • 20865082000133 ()
  • 10865082000136 ()


  • Surgical retractor/retraction system blade, reusable
  • Operating room light

Disposable Blade Assembly - 10861994000288

Endoscopic Carpal Tunnel Release Disposable Blade Assembly
Hand Biomechanics Lab Inc
CTR-455
In Commercial Distribution

  • 00861994000281 ()
  • 10861994000288 ()
CTR-455

  • Hand ligament surgical release instrument

NITE SHIELD Nitrile Powder Free Examination Gloves, Black - 10860010351342

NITE SHIELD Nitrile Powder Free Examination Gloves, Black, Size XX-Large
Medzah Industries
NSMD06
In Commercial Distribution

  • 20860010351349 ()
  • 10860010351342 ()
  • 00860010351345 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

NITE SHIELD Nitrile Powder Free Examination Gloves, Black - 10860010351335

Nitrile Powder Free Examination Gloves, Black, Size X-Large
Medzah Industries
NSMD05
In Commercial Distribution

  • 20860010351332 ()
  • 10860010351335 ()
  • 00860010351338 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

NITE SHIELD Nitrile Powder Free Examination Gloves, Black - 10860010351328

Nitrile Powder Free Examination Gloves, Black, Size Large
Medzah Industries
NSMD04
In Commercial Distribution

  • 20860010351325 ()
  • 10860010351328 ()
  • 00860010351321 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

NITE SHIELD Nitrile Powder Free Examination Gloves, Black - 10860010351311

Nitrile Powder Free Examination Gloves, Black, Size Medium
Medzah Industries
NSMD03
In Commercial Distribution

  • 20860010351318 ()
  • 10860010351311 ()
  • 00860010351314 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

NITE SHIELD Nitrile Powder Free Examination Gloves, Black - 10860010351304

Nitrile Powder Free Examination Gloves, Black, Size Small
Medzah Industries
NSMD02
In Commercial Distribution

  • 00860010351307 ()
  • 10860010351304 ()
  • 20860010351301 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

LaproGlide - 10860009758398

Laparoscopic L- Wire Electrode, 33cm Length, Foot Control, PTFE
Surgical Principals, Inc
U0100S
In Commercial Distribution

  • 00860009758391 ()
  • 10860009758398 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
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