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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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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

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™ - 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™ - 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™ - 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

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

E.M Adams co, inc. - 18100013407427

BELT
E.M. ADAMS, INC.
EP26-63391-1
Not in Commercial Distribution

  • 58100013407418 ()
  • 18100013407427 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407403

BELT
E.M. ADAMS, INC.
EP26-63375-1
Not in Commercial Distribution

  • 58100013407395 ()
  • 18100013407403 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407380

BELT
E.M. ADAMS, INC.
EP26-63350XL-1
Not in Commercial Distribution

  • 58100013407371 ()
  • 18100013407380 ()

  • 2" X 72" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407366

BELT
E.M. ADAMS, INC.
EP26-63350-1
Not in Commercial Distribution

  • 58100013407357 ()
  • 18100013407366 ()

  • 2" X 54" BELT


  • Gait rehabilitation system harness

E.M Adams co, inc. - 18100013407342

BELT
E.M. ADAMS, INC.
EP26-63340XL-1
Not in Commercial Distribution

  • 58100013407333 ()
  • 18100013407342 ()

  • 2" X 72" BELT


  • 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

Macro Depth Electrode - 00841823109705

No Description
Ad-Tech Medical Instrument Corporation
9
In Commercial Distribution

  • 00841823109705 ()
BF08R-SP61X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109682

No Description
Ad-Tech Medical Instrument Corporation
7
In Commercial Distribution

  • 00841823109682 ()
BF09R-SP21X-0CC

  • Depth electrode

Macro Depth Electrode - 00841823109668

No Description
Ad-Tech Medical Instrument Corporation
5
In Commercial Distribution

  • 00841823109668 ()
BF10R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109644

No Description
Ad-Tech Medical Instrument Corporation
3
In Commercial Distribution

  • 00841823109644 ()
BF10R-SP61X-0C3

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109477

No Description
Ad-Tech Medical Instrument Corporation
SD14R-SP05X-000
In Commercial Distribution

  • 00841823109477 ()
SD14R-SP05X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109453

No Description
Ad-Tech Medical Instrument Corporation
SD13R-SP45X-0T2
In Commercial Distribution

  • 00841823109453 ()
SD13R-SP45X-0T2

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109439

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP10X-000
In Commercial Distribution

  • 00841823109439 ()
SD12R-SP10X-000

  • Depth electrode

Spencer Probe Depth Electrode - 00841823109415

No Description
Ad-Tech Medical Instrument Corporation
SD12R-SP06X-000
In Commercial Distribution

  • 00841823109415 ()
SD12R-SP06X-000

  • Depth electrode

Macro Depth Electrode - 00841823109729

No Description
Ad-Tech Medical Instrument Corporation
11
In Commercial Distribution

  • 00841823109729 ()
BF08R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109712

No Description
Ad-Tech Medical Instrument Corporation
10
In Commercial Distribution

  • 00841823109712 ()
BF08R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109699

No Description
Ad-Tech Medical Instrument Corporation
8
In Commercial Distribution

  • 00841823109699 ()
BF09R-SP05X-0BE

  • Depth electrode

Macro Depth Electrode - 00841823109675

No Description
Ad-Tech Medical Instrument Corporation
6
In Commercial Distribution

  • 00841823109675 ()
BF09R-SP61X-0CC

  • Depth electrode

Macro Depth Electrode - 00841823109651

No Description
Ad-Tech Medical Instrument Corporation
4
In Commercial Distribution

  • 00841823109651 ()
BF10R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109637

No Description
Ad-Tech Medical Instrument Corporation
2
In Commercial Distribution

  • 00841823109637 ()
BF12R-SP05X-0BH

  • Depth electrode

Macro Depth Electrode - 00841823109620

No Description
Ad-Tech Medical Instrument Corporation
1
In Commercial Distribution

  • 00841823109620 ()
BF12R-SP21X-0C3

  • Depth electrode

Macro Depth Electrode - 00841823109613

No Description
Ad-Tech Medical Instrument Corporation
0
In Commercial Distribution

  • 00841823109613 ()
BF12R-SP61X-0C3

  • Depth electrode

Depth Electrode - 00841823109576

No Description
Ad-Tech Medical Instrument Corporation
MM31A-SP53X-000
In Commercial Distribution

  • 00841823109576 ()
MM31A-SP53X-000

  • Depth electrode

Depth Electrode - 00841823109569

No Description
Ad-Tech Medical Instrument Corporation
MM29A-SP52X-000
In Commercial Distribution

  • 00841823109569 ()
MM29A-SP52X-000

  • Depth electrode

Depth Electrode - 00841823109552

No Description
Ad-Tech Medical Instrument Corporation
MM32D-SP05X-000
In Commercial Distribution

  • 00841823109552 ()
MM32D-SP05X-000

  • Depth electrode
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