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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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PRIMO - 00840216114005

60" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB60QRP
In Commercial Distribution

  • 00840216114005 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113992

60" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB60QRNB
In Commercial Distribution

  • 00840216113992 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113985

60" Gait Belt, Quick Release Buckle, Natural
Asp Global, LLC
GB60QRN
In Commercial Distribution

  • 00840216113985 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113978

60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107052

BELT, QUICK CLEAN GAIT, PINK, 36", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM36PK
In Commercial Distribution

  • 00840216107052 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107045

BELT, QUICK CLEAN GAIT, BLUE, 60", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM60BL
In Commercial Distribution

  • 00840216107045 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107038

BELT, QUICK CLEAN GAIT, BLACK, 72", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM72BK
In Commercial Distribution

  • 00840216107038 ()


  • Gait rehabilitation system harness

PRIMO - 00840216105737

BELT GAIT NATURAL STRIPES WITH BLUE & RED 54"
Asp Global, LLC
GBANS54
In Commercial Distribution

  • 00840216105737 ()


  • Gait rehabilitation system harness

PRIMO/ASP MEDICAL - 00840216100138

72" GAIT BELT - NATURAL, 1/EA
Asp Global, LLC
GB72MBN
In Commercial Distribution

  • 00840216100138 ()


  • Gait rehabilitation system harness

Walking Harness - Tollos - 00817956023126

Walking Harness - XXLarge - Orange Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXXX
In Commercial Distribution

  • 00817956023126 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness

Walking Harness - Tollos - 00817956023119

Walking Harness - XLarge - Blue Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSXX
In Commercial Distribution

  • 00817956023119 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness

Walking Harness - Tollos - 00817956023102

Walking Harness - Large - Green Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSX
In Commercial Distribution

  • 00817956023102 ()

  • Height: 21 Inch
  • Width: 16 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness

Walking Harness - Tollos - 00817956023096

Walking Harness - Medium - Yellow Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WS
In Commercial Distribution

  • 00817956023096 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness

Walking Harness - Tollos - 00817956023089

Walking Harness - Small - Red Binding - 4 Loop - Tricot Material - Reuseable
1073849 Ontario Limited
TSC015WSP
In Commercial Distribution

  • 00817956023089 ()

  • Height: 21 Inch
  • Width: 17 Inch
  • Depth: 4 Inch


  • Gait rehabilitation system harness

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

30" TRANSFER BOARD W/HANDLES - 00610570006120

No Description
Bird & Cronin, LLC
08141349
In Commercial Distribution

  • 00610570006120 ()


  • Gait rehabilitation system harness

54" WALKING BELT PASTEL STRIPE - 00610570003136

No Description
Bird & Cronin, LLC
08140580
In Commercial Distribution

  • 00610570003136 ()


  • Gait rehabilitation system harness

45" WALKING BELT PASTEL STRIPE - 00610570002801

No Description
Bird & Cronin, LLC
08140480
In Commercial Distribution

  • 00610570002801 ()


  • Gait rehabilitation system harness

MediChoice - 20885632061643

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle 2x72inch Yellow Latex Free Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT723
In Commercial Distribution

  • 10885632061646 ()
  • 20885632061643 ()


  • Gait rehabilitation system harness

MediChoice - 20885632061629

Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle 2x54 Inch Yellow Latex Free Reusable MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT543
In Commercial Distribution

  • 10885632061622 ()
  • 20885632061629 ()


  • Gait rehabilitation system harness

SYNCHROMED ® II - 00613994779229

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

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" WOOD TRANSFER BOARD - 00610570006113

No Description
Bird & Cronin, LLC
08141340
In Commercial Distribution

  • 00610570006113 ()


  • Gait rehabilitation system harness

24" WOOD TRANSFER BOARD - 00610570006106

No Description
Bird & Cronin, LLC
08141339
In Commercial Distribution

  • 00610570006106 ()


  • Gait rehabilitation system harness

Auragen™ - 10381780036524

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

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

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

Integra® - 10381780037088

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

Auragen™ - 10381780036531

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

Auragen™ - 10381780036517

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

Auragen™ - 10381780036456

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

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™ - 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

Integra® - 10381780034766

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

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
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