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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The gait trainer conveys mechanical energy needed to perform gait therapy via foot plates to the sole of the patient’s feet. The foot plates follow a pattern that is derived from healthy subjects. The body weight support system secures the patient from falling and further allows to reduce the weight on the patient’s feet.
medica - Medizintechnik GmbH
01.XX.XX
In Commercial Distribution

  • 04041925002775 ()


  • Treadmill/elliptical gait rehabilitation system
No Description
CUREXO, Inc.
MW-V100
In Commercial Distribution

  • 08800043810121 ()


  • Treadmill/elliptical gait rehabilitation system
MW-S200
CUREXO, Inc.
MW-S200
In Commercial Distribution

  • 08800043810022 ()
AC-00000-000

  • Treadmill/elliptical gait rehabilitation system
Bariatric Harness for persons 300-600 lbs
M.A.S.S. Rehab, LLC
Bariatric
In Commercial Distribution

  • G505MRUHB0 ()


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

  • G505MRPH0 ()


  • Gait rehabilitation system harness
Simple two-loop spotting harness for gait and balance training.
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRMS0 ()


  • Gait rehabilitation system harness
Harness for Healing Solutions Robotic Trainer
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRHSH0 ()


  • Gait rehabilitation system harness
Balance harness for balance training activities
M.A.S.S. Rehab, LLC
Standard
In Commercial Distribution

  • G505MRBHS0 ()


  • Gait rehabilitation system harness
The OMEGO is a robotic pre-gait therapy system for the rehabilitation of patients with neurologic disorders.
tyromotion GmbH
1
In Commercial Distribution

  • 09120077180083 ()


  • Treadmill/elliptical gait rehabilitation system
The LEXO is a mechatronic therapy system for body weight-supported gait rehabilitation of patients with a limited ability to walk.
tyromotion GmbH
R1
In Commercial Distribution

  • 09120077180076 ()


  • Treadmill/elliptical gait rehabilitation system
Gait Belt- Plastic Buckle, Multi-Color, 60"x2"
Dynarex Corporation
4354
In Commercial Distribution

  • 00616784435435 ()
  • 00616784435411 ()


  • 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- Metal Buckle, Natural Color, 60"x2"
Dynarex Corporation
4352
In Commercial Distribution

  • 00616784435237 ()
  • 00616784435213 ()


  • 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
Gait Belt, Antimicrobial, Metal Buckle, Blue and White
Dynarex Corporation
4344
In Commercial Distribution

  • 00616784434438 ()
  • 00616784434414 ()


  • Gait rehabilitation system harness
Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution

  • 00810335020228 ()


  • Implantable intrathecal infusion pump, programmable
The Prometra Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter.
Flowonix Medical, Inc.
11827
In Commercial Distribution

  • 00810335020082 ()


  • Implantable intrathecal infusion pump, programmable
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 72 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT722
In Commercial Distribution

  • 10885632110849 ()
  • 50885632110847 ()


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 72 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT721
In Commercial Distribution

  • 10885632110832 ()
  • 50885632110830 ()


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 60 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT602
In Commercial Distribution

  • 10885632110825 ()
  • 50885632110823 ()


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 60 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT601
In Commercial Distribution

  • 10885632110818 ()
  • 50885632110816 ()


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Natural 2 X 54 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT542
In Commercial Distribution

  • 10885632110801 ()
  • 50885632110809 ()


  • Gait rehabilitation system harness
Gait Belt Heavy-Duty Cotton Webbing Treated With Bacteriostatic Agent Nickel-Plated Metal Buckle Pastel Stripe 2 X 54 Inch Not Made With Natural Rubber Latex MediChoice
OWENS & MINOR DISTRIBUTION, INC.
GAIT541
In Commercial Distribution

  • 10885632110795 ()
  • 50885632110793 ()


  • Gait rehabilitation system harness
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)
AU6D10L5
Not in Commercial Distribution

  • M272AU6D10L51 ()
  • 10381780036449 ()

  • 6 platinum contacts


  • 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)
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
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