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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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SynCage - 10705034732053

GRAFT PACKING BLOCK-LARGE FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.074
In Commercial Distribution

  • 07611819534780 ()
  • H981038250740 ()
  • 10705034732053 ()
03825074

  • Bone graft packing block

SynCage - 10705034732046

GRAFT PACKING BLOCK-MEDIUM FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.073
In Commercial Distribution

  • 07611819534773 ()
  • H981038250730 ()
  • 10705034732046 ()
03825073

  • Bone graft packing block

SynCage - 10705034732039

GRAFT PACKING BLOCK-SMALL FOR SYNCAGE EVOLUTION
Synthes GmbH
03.825.072
In Commercial Distribution

  • 07611819534766 ()
  • H981038250720 ()
  • 10705034732039 ()
03825072

  • Bone graft packing block

SynFix-LR - 10705034722276

PACKING BLOCK FOR 30MM DEPTH/ 38MM WIDTH SYNFIX(TM)-LR
SYNTHES (U.S.A.) LP
03.802.042
Not in Commercial Distribution

  • 07611819297425 ()
  • H981038020420 ()
  • 10705034722276 ()
03802042

  • Bone graft packing block

SynFix-LR - 10705034722269

PACKING BLOCK FOR 26MM DEPTH/ 32MM WIDTH SYNFIX(TM)-LR
SYNTHES (U.S.A.) LP
03.802.041
Not in Commercial Distribution

  • 07611819791268 ()
  • H981038020410 ()
  • 10705034722269 ()
03802041

  • Bone graft packing block

Zero-P VA - 10705034720838

PACKING BLOCK FOR ZERO-P VA IMPLANTS
Synthes GmbH
03.647.984
In Commercial Distribution

  • 07611819404502 ()
  • H981036479840 ()
  • 10705034720838 ()
03647984

  • Bone graft packing block

NA - 10705034778204

ACF GRAFT PACKING BLOCK
Synthes GmbH
396.996
In Commercial Distribution

  • H9813969960 ()
  • 10705034778204 ()
396996

  • Bone graft packing block

ALIF - 10705034774800

ALIF GRAFT PACKING BLOCK
Synthes GmbH
389.155
In Commercial Distribution

  • H9813891550 ()
  • 10705034774800 ()
389155

  • Bone graft packing block

Savant Lumbar Interbody Fusion System - B648C2553000

ALIF Graft Packing Block
CURITEVA, INC.
C255-300
In Commercial Distribution

  • B648C2553000 ()


  • Bone graft packing block

Indego Therapy - M704501110001

Indego Therapy is a computerized, adjustable-fit powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-110-001
In Commercial Distribution

  • M704501110001 ()


  • Programmable ambulation exoskeleton, clinical

Indego - M704501100000

Indego is a computerized, powered exoskeleton, designed to restore walking function for impaired individuals.
EKSO BIONICS, INC.
501-100-000
In Commercial Distribution

  • M704501100000 ()


  • Programmable ambulation exoskeleton, clinical

Ekso - B1431200000

The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker.
EKSO BIONICS, INC.
GT
In Commercial Distribution

  • B1431200000 ()


  • Programmable ambulation exoskeleton, clinical

EksoNR - B168EKSONR0

EKSO BIONICS SYSTEM, Ekso NR
EKSO BIONICS, INC.
EKSONR
In Commercial Distribution

  • B168EKSONR0 ()
EKSONR

  • Programmable ambulation exoskeleton, clinical

EksoGT - B168EKSOGT0

EKSO BIONICS SYSTEM, Ekso GT
EKSO BIONICS, INC.
EKSOGT
In Commercial Distribution

  • B168EKSOGT0 ()
EKSOGT

  • Programmable ambulation exoskeleton, clinical

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

Unloading Harness - G505MRUHS0

Unloading harness for gait training
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRUHS0 ()


  • Gait rehabilitation system harness

Unloading Harness Bariatric - G505MRUHB0

Bariatric Harness for persons 300-600 lbs
M.A.S.S. Rehab, LLC
Bariatric
In Commercial Distribution

  • G505MRUHB0 ()


  • Gait rehabilitation system harness

Pediatric Harness - G505MRPH0

Pediatiric harness for gait training.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRPH0 ()


  • Gait rehabilitation system harness
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