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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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Auragen™ - 10381780036449

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

Auragen™ - 10381780036432

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

Auragen™ - 10381780036326

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

Auragen™ - 10381780036319

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

Auragen™ - 10381780036302

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

Auragen™ - 10381780036111

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

Auragen™ - 10381780036104

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

Gait Belt - 00616784435411

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

  • 00616784435435 ()
  • 00616784435411 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784435312

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

  • 00616784435336 ()
  • 00616784435312 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784435213

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

  • 00616784435237 ()
  • 00616784435213 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784434513

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

  • 00616784434537 ()
  • 00616784434513 ()


  • Gait rehabilitation system harness

Gait Belt - 00616784434414

Gait Belt, Antimicrobial, Metal Buckle, Blue and White
DYNAREX CORPORATION
4344
In Commercial Distribution

  • 00616784434438 ()
  • 00616784434414 ()


  • Gait rehabilitation system harness

Aretech Premium Harness - 00850018836159

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

Aretech Premium Harness - 00850018836142

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

Aretech Premium Harness - 00850018836135

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

Aretech Premium Harness - 00850018836128

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

Aretech Premium Harness - 00850018836111

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

Aretech Premium Harness - 00850018836104

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

Aretech Premium Harness - 00850018836098

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

Aretech Premium Harness - 00850018836081

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

Aretech Premium Harness - 00850018836074

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 - 00850040235012

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

SYNCHROMED® II - 00643169508156

PUMP 8637-40 SYNCHMED II 40ML POTTED FTS
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169508156 ()


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00643169508149

PUMP 8637-20 SYNCHMED II 20ML POTTED FTS
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169508149 ()


  • Implantable intrathecal infusion pump, programmable

108" WALKING BELT BLUE - 00610570187317

No Description
Bird & Cronin, LLC
08141082
In Commercial Distribution

  • 00610570187317 ()
  • 00610570005000 ()


  • Gait rehabilitation system harness

72" WALKING BELT BLUE - 00610570187300

No Description
Bird & Cronin, LLC
08140722
In Commercial Distribution

  • 00610570187300 ()
  • 00610570003785 ()


  • Gait rehabilitation system harness

60" WALKING BELT BLUE - 00610570187294

No Description
Bird & Cronin, LLC
08140602
In Commercial Distribution

  • 00610570187294 ()
  • 00610570003235 ()


  • Gait rehabilitation system harness

54" WALKING BELT BLUE - 00610570187287

No Description
Bird & Cronin, LLC
08140542
In Commercial Distribution

  • 00610570187287 ()
  • 00610570003037 ()


  • Gait rehabilitation system harness

45" WALKING BELT BLUE - 00610570187270

No Description
Bird & Cronin, LLC
08140452
In Commercial Distribution

  • 00610570187270 ()
  • 00610570002603 ()


  • Gait rehabilitation system harness

108" GAIT BELT NATURAL - 00610570163250

No Description
Bird & Cronin, LLC
90000108
In Commercial Distribution

  • 00610570163250 ()


  • Gait rehabilitation system harness

SYNCHROMED ® II - 00643169100831

PUMP 8637-20 SYNCHMED II 20ML PF
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169100831 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED ® II - 00643169100824

PUMP 8637-40 SYNCHMED II 40ML PF
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169100824 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

PMT® CORPORATION - SPHENOIDAL - 10650551092862

SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122
In Commercial Distribution

  • 10650551092862 ()
  • 00650551092865 ()
2122

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092855

PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09
In Commercial Distribution

  • 10650551092855 ()
  • 00650551092858 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-09

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092848

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05
In Commercial Distribution

  • 10650551092848 ()
  • 00650551092841 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-05

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092831

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03
In Commercial Distribution

  • 10650551092831 ()
  • 00650551092834 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092824

PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03
In Commercial Distribution

  • 10650551092824 ()
  • 00650551092827 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-31-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092817

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03
In Commercial Distribution

  • 10650551092817 ()
  • 00650551092810 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-03

  • Depth electrode

PMT® CORPORATION - SPHENOIDAL - 10650551092800

STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03
In Commercial Distribution

  • 10650551092800 ()
  • 00650551092803 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03

  • Depth electrode

SynchroMed® II - 00643169530126

PUMP 8637-40 SYNCHMED II 40ML DLC MOTOR
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169530126 ()

  • Total Volume: 40.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

SynchroMed® II - 00643169530119

PUMP 8637-20 SYNCHMED II 20ML DLC MOTOR
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169530119 ()

  • Total Volume: 20.0 Milliliter


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00643169630512

PUMP 8637-40 SYNCHMED II 40ML EMAN SYMBL
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169630512 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable

SYNCHROMED® II - 00643169630505

PUMP 8637-20 SYNCHMED II 20ML EMAN SYMBL
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169630505 ()

  • Reservoir Volume 20 mL


  • Implantable intrathecal infusion pump, programmable

108" SIDE RELEASE WALKING BELT BLUE - 00610570022823

No Description
Bird & Cronin, LLC
08146882
In Commercial Distribution

  • 00610570022823 ()


  • Gait rehabilitation system harness

72" SIDE RELEASE WALKING BELT BLUE - 00610570022618

No Description
Bird & Cronin, LLC
08146722
In Commercial Distribution

  • 00610570022618 ()


  • Gait rehabilitation system harness

60" SIDE RELEASE WALKING BELT BLUE - 00610570022335

No Description
Bird & Cronin, LLC
08146602
In Commercial Distribution

  • 00610570022335 ()


  • Gait rehabilitation system harness

54" SIDE RELEASE BELT ROYAL BLUE - 00610570022236

No Description
Bird & Cronin, LLC
08146542
In Commercial Distribution

  • 00610570022236 ()


  • Gait rehabilitation system harness

45" SIDE RELEASE WALKING BELT BLUE - 00610570021918

No Description
Bird & Cronin, LLC
08146452
In Commercial Distribution

  • 00610570021918 ()


  • Gait rehabilitation system harness

30" TRANSFER BOARD W/HANDLES - 00610570006120

No Description
Bird & Cronin, LLC
08141349
In Commercial Distribution

  • 00610570006120 ()


  • Gait rehabilitation system harness

30" WOOD TRANSFER BOARD - 00610570006113

No Description
Bird & Cronin, LLC
08141340
In Commercial Distribution

  • 00610570006113 ()


  • Gait rehabilitation system harness
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