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(TM) Electrode, sterile, D.ZAP(Z), for use with Nexframe(R)
FHC, INC.
5005Z-00277
In Commercial Distribution

  • 10873263002770 ()
  • 00873263002773 ()

  • Impedance: Megaohms
  • Length: 234.2 Millimeter
  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
5005Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Nexframe(R)
FHC, INC.
5005L-00273
In Commercial Distribution

  • 10873263002732 ()
  • 00873263002735 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
5005L

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.Zap(Z), for use with Platform
FHC, INC.
44975Z-00267
In Commercial Distribution

  • 10873263002671 ()
  • 00873263002674 ()

  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 205.72 Millimeter
  • Length: 10 Millimeter
  • Length: 220.72 Millimeter
44975Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, D.ZAP(L), for use with Platform
FHC, INC.
44975L-00263
In Commercial Distribution

  • 10873263002633 ()
  • 00873263002636 ()

  • Impedance: Megaohms
  • Length: 220.72 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 10 Millimeter
  • Length: 205.72 Millimeter
44975L

  • Depth electrode
microTargeting(TM) Electrode, 1x, sterile, R.ZAP, Platform
FHC, INC.
44970R-00259
In Commercial Distribution

  • 10873263002596 ()
  • 00873263002599 ()

  • Length: 205.72 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
  • Length: 220.72 Millimeter
  • Length: 10 Millimeter
44970R

  • Depth electrode
microTargeting LP+ Patient Lead, Sterile, for use with microTargting Electrodes
FHC, INC.
66-EL-LP-00258
In Commercial Distribution

  • 00873263002582 ()
66-EL-LP

  • Depth electrode
microTargeting Electrode Cable w/ Alligator Clips, Sterile, for use with microTargeting Electrodes
FHC, INC.
66-EL-EC-01-00257
In Commercial Distribution

  • 00873263002575 ()
66-EL-EC-01

  • Depth electrode
microTargeting(TM) Electrode, 1x, sterile, single, D.ZAP(Z), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685Z-00254
In Commercial Distribution

  • 10873263002541 ()
  • 00873263002544 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
34685Z

  • Depth electrode
microTargeting(TM) Electrode, sterile, single, D.ZAP(L), T=30 for use with Frame and STar or MT Drive
FHC, INC.
34685L-00252
In Commercial Distribution

  • 10873263002527 ()
  • 00873263002520 ()

  • Length: 256.4 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
34685L

  • Depth electrode
microTargeting(TM) Electrode, differential, sterile, single, 1 Meg for use with Frame and STar or MT Drive
FHC, INC.
34680R-00250
In Commercial Distribution

  • 10873263002503 ()
  • 00873263002506 ()

  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 256.4 Millimeter
  • Length: 271.4 Millimeter
34680R

  • Depth electrode
microTargeting(TM) Electrode, sterile, 1x, array, D.ZAP(Z) for use with Frame and STar or MT Drive
FHC, INC.
22675Z-00246
In Commercial Distribution

  • 10873263002466 ()
  • 00873263002469 ()

  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
22675Z

  • Depth electrode
microTargeting Array Electrode, 1x, sterile, D.ZAP(L) for use with Frame, STar or MT Drive
FHC, INC.
22675L-00244
In Commercial Distribution

  • 10873263002442 ()
  • 00873263002445 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 0.55 Millimeter
22675L

  • Depth electrode
microTargeting Array Electrode, sterile, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
22670R-00242
In Commercial Distribution

  • 10873263002428 ()
  • 00873263002421 ()

  • Impedance: Megaohms
  • Length: 261.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 276.5 Millimeter
  • Length: 10 Millimeter
22670R

  • Depth electrode
microTargeting Electrode Cable, Sterile, for use with microTargeting Electrodes
FHC, INC.
66-EL-EC-00155
In Commercial Distribution

  • 00873263001554 ()
66-EL-EC

  • Depth electrode
microTargeting Electrode Cable
FHC, INC.
FC1020-00151
In Commercial Distribution

  • 00873263001516 ()
FC1020

  • Depth electrode
microTargeting Electrode Cable
FHC, INC.
FC1020-00139
In Commercial Distribution

  • 00873263001394 ()
FC1020

  • Depth electrode
Size: 3X-Large (waist circumference measured 2" below belly button: 51 - 57 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-3XL
In Commercial Distribution

  • 00850018836159 ()


  • Gait rehabilitation system harness
Size: XX-Large (waist circumference measured 2" below belly button: 46 - 51 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-2XL
In Commercial Distribution

  • 00850018836142 ()


  • Gait rehabilitation system harness
Size: X-Large (waist circumference measured 2" below belly button: 41 - 46 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-XL
In Commercial Distribution

  • 00850018836135 ()


  • Gait rehabilitation system harness
Size: Large (waist circumference measured 2" below belly button: 36 - 41 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-0L
In Commercial Distribution

  • 00850018836128 ()


  • Gait rehabilitation system harness
Size: Medium (waist circumference measured 2" below belly button: 31 - 36 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-0M
In Commercial Distribution

  • 00850018836111 ()


  • Gait rehabilitation system harness
Size: Small (waist circumference measured 2" below belly button: 26 - 31 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-0S
In Commercial Distribution

  • 00850018836104 ()


  • Gait rehabilitation system harness
Size: X-Small (waist circumference measured 2" below belly button: 22 - 26 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-XS
In Commercial Distribution

  • 00850018836098 ()


  • Gait rehabilitation system harness
Size: Pediatric (waist circumference measured 2" below belly button: 22 - 26 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-0P
In Commercial Distribution

  • 00850018836081 ()


  • Gait rehabilitation system harness
Size: Toddler (waist circumference measured 2" below belly button: 20 - 23 inches). The Aretech Premium Harness is designed for use with Aretech products.
ARETECH, LLC
AH-0T
In Commercial Distribution

  • 00850018836074 ()


  • Gait rehabilitation system harness
LiteGait is a Physical Therapy Patient lifting device that allows for body weight support gait therapy.
Mobility Research, Inc.
ALL LiteGait devices
In Commercial Distribution

  • 00850040235012 ()
N/A

  • Gait rehabilitation system harness
Gait Belt- Plastic Buckle, Multi-Color, 60"x2"
DYNAREX CORPORATION
4354
In Commercial Distribution

  • 00616784435435 ()
  • 00616784435411 ()


  • Gait rehabilitation system harness
Gait Belt- Metal Buckle, Natural Color, 60"x2"
DYNAREX CORPORATION
4352
In Commercial Distribution

  • 00616784435237 ()
  • 00616784435213 ()


  • Gait rehabilitation system harness
Gait Belt, Antimicrobial, Metal Buckle, Blue and White
DYNAREX CORPORATION
4344
In Commercial Distribution

  • 00616784434438 ()
  • 00616784434414 ()


  • Gait rehabilitation system harness
Gait Belt, Metal Buckle, Multi-color, 60"x2"
DYNAREX CORPORATION
4353
In Commercial Distribution

  • 00616784435336 ()
  • 00616784435312 ()


  • Gait rehabilitation system harness
Gait Belt, Wipeable, Vinyl, Plastic Buckle, Red and Black
DYNAREX CORPORATION
4345
In Commercial Distribution

  • 00616784434537 ()
  • 00616784434513 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146545
In Commercial Distribution

  • 50610570149945 ()
  • 00610570149940 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140780
In Commercial Distribution

  • 50610570004046 ()
  • 00610570004041 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140680
In Commercial Distribution

  • 50610570003612 ()
  • 00610570003617 ()


  • Gait rehabilitation system harness
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
40M08
Not in Commercial Distribution

  • M27240M081 ()
  • 10381780034766 ()

  • Insertion needle 64mm Length


  • Depth electrode
The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cortical electrical activity specifically at the undersurface of the temporal lobe. It has one platinum contact and is supplied with an insertion needle.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
EDSEP
Not in Commercial Distribution

  • M272EDSEP1 ()
  • 10381780037088 ()


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D5L25
Not in Commercial Distribution

  • M272AU8D5L251 ()
  • 10381780036531 ()

  • 8 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L5
Not in Commercial Distribution

  • M272AU8D10L51 ()
  • 10381780036524 ()

  • 8 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU8D10L25
Not in Commercial Distribution

  • M272AU8D10L251 ()
  • 10381780036517 ()

  • 8 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D5L25
Not in Commercial Distribution

  • M272AU6D5L251 ()
  • 10381780036456 ()

  • 6 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D10L5
Not in Commercial Distribution

  • M272AU6D10L51 ()
  • 10381780036449 ()

  • 6 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU6D10L25
Not in Commercial Distribution

  • M272AU6D10L251 ()
  • 10381780036432 ()

  • 6 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D5L25
Not in Commercial Distribution

  • M272AU4D5L251 ()
  • 10381780036326 ()

  • 4 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L5
Not in Commercial Distribution

  • M272AU4D10L51 ()
  • 10381780036319 ()

  • 4 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU4D10L25
Not in Commercial Distribution

  • M272AU4D10L251 ()
  • 10381780036302 ()

  • 4 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU12D5L25
Not in Commercial Distribution

  • M272AU12D5L251 ()
  • 10381780036111 ()

  • 12 platinum contacts


  • Depth electrode
The Auragen™ depth electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are inserted stereotaxically into the brain. Depth electrodes are available with 4 to 12 platinum/iridium contacts. The type of depth electrode used is dependent on the procedure and the size of area being tested.
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
AU10D5L25
Not in Commercial Distribution

  • M272AU10D5L251 ()
  • 10381780036104 ()

  • 10 platinum contacts


  • Depth electrode
PUMP 8637-20 SM2 20ML EMAN US JUN BATRY
MEDTRONIC, INC.
8637-20
Not in Commercial Distribution

  • 00613994779229 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-170
In Commercial Distribution

  • 09348215055974 ()


  • Surgical implant template, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-168
In Commercial Distribution

  • 09348215055967 ()


  • Surgical implant template, reusable
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