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

  • G505MRUHS0 ()


  • Gait rehabilitation system harness
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
Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Codman Neuro Sciences Sàrl
91-4285US
In Commercial Distribution

  • 20886704071454 ()
  • 10886704071457 ()
914285US

  • Implantable intrathecal infusion pump, programmable
Bolus Kit
Medos International Sàrl
91-4284US
In Commercial Distribution

  • 10886704071440 ()
914284US

  • Implantable intrathecal infusion pump, programmable
Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable
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
No Description
HOCOMA AG
Nanos 1.3
In Commercial Distribution

  • 07640174660490 ()
63061

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 PE Motivation
In Commercial Distribution

  • 07640174660483 ()
63060

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 AD Motivation
In Commercial Distribution

  • 07640174660476 ()
63059

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 Kombi Motivation
In Commercial Distribution

  • 07640174660469 ()
63058

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 PE
In Commercial Distribution

  • 07640174660452 ()
63057

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 AD
In Commercial Distribution

  • 07640174660445 ()
63056

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 Kombi
In Commercial Distribution

  • 07640174660438 ()
63055

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 FD PE
In Commercial Distribution

  • 07640174660421 ()
63054

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 FD AD
In Commercial Distribution

  • 07640174660414 ()
63053

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro 6.3 FD Kombi
In Commercial Distribution

  • 07640174660407 ()
63052

  • Treadmill/elliptical gait rehabilitation system
microTargeting™ Electrode, tungsten, non sterile, 6x, D.ZAP(Z)
FHC, INC.
MTDWZN(AR)(MP7)-00920
In Commercial Distribution

  • 00873263009208 ()
  • 10873263009205 ()
MTDWZN(AR)(MP7)

  • Depth electrode
microTargeting™ Electrode, differential, tungsten, 6x,D.ZAP(L), nonsterile
FHC, INC.
MTDWLN(BP)(BP6)-00868
In Commercial Distribution

  • 00873263008683 ()
  • 10873263008680 ()
MTDWLN(BP)(BP6)

  • Depth electrode
microTargeting™ Electrode, non sterile, 6x, Array, D.ZAP(Z), T=30 for use with frame, STar or MT Drive
FHC, INC.
MTDWZN(AR)(AR7)-00863
In Commercial Distribution

  • 00873263008638 ()
  • 10873263008635 ()
MTDWZN(AR)(AR7)

  • Depth electrode
microTargeting™ Platform Platinum 6X Non Sterile
FHC, INC.
45335Z-00799
In Commercial Distribution

  • 10873263007997 ()
  • 00873263007990 ()

  • Length: 212.72 Millimeter
  • Impedance: Megaohms
  • Length: 3 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 220.72 Millimeter
45335Z

  • Depth electrode
microTargeting™ Platform 6X Non Sterile
FHC, INC.
44335Z-00797
In Commercial Distribution

  • 10873263007973 ()
  • 00873263007976 ()

  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 212.72 Millimeter
  • Length: 220.72 Millimeter
  • Length: 3 Millimeter
44335Z

  • Depth electrode
microTargeting™ Single Frame Platinum 6x Non Sterile
FHC, INC.
35325Z-00795
In Commercial Distribution

  • 10873263007959 ()
  • 00873263007952 ()

  • Outer Diameter: 0.86 Millimeter
  • Length: 271.4 Millimeter
  • Length: 263.4 Millimeter
  • Length: 3 Millimeter
  • Impedance: Megaohms
35325Z

  • Depth electrode
microTargeting™ Frame Single Tungsten 6X Non Sterile
FHC, INC.
34325Z-00793
In Commercial Distribution

  • 10873263007935 ()
  • 00873263007938 ()

  • Length: 263.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 3 Millimeter
  • Length: 271.4 Millimeter
  • Impedance: Megaohms
34325Z

  • Depth electrode
microTargeting™ Array Frame Platinum 6X Non Sterile
FHC, INC.
25335Z-00791
In Commercial Distribution

  • 10873263007911 ()
  • 00873263007914 ()

  • Outer Diameter: 0.56 Millimeter
  • Length: 276.5 Millimeter
  • Length: 3 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
25335Z

  • Depth electrode
microTargeting™ Array Electrodes 6x Non Sterile
FHC, INC.
22335Z-00789
In Commercial Distribution

  • 10873263007898 ()
  • 00873263007891 ()

  • Length: 3 Millimeter
  • Length: 276.5 Millimeter
  • Length: 268.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
22335Z

  • Depth electrode
microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00755
In Commercial Distribution

  • 10873263007553 ()
  • 00873263007556 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 249.2 Millimeter
FC5000

  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00752
In Commercial Distribution

  • 10873263007522 ()
  • 00873263007525 ()

  • Length: 227.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2004

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single and Array, D.ZAP(L) , T=30 for use with NexFrame and MT Drive or NexDrive
FHC, INC.
FC2003-00751
In Commercial Distribution

  • 10873263007515 ()
  • 00873263007518 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
FC2003

  • Depth electrode
microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00750
In Commercial Distribution

  • 10873263007508 ()
  • 00873263007501 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
FC2002

  • Depth electrode
microTargeting Differential Electrode 5x, D.ZAP(L), Sterile, Array, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC2001-00749
In Commercial Distribution

  • 10873263007492 ()
  • 00873263007495 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 261.5 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2001

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00748
In Commercial Distribution

  • 10873263007485 ()
  • 00873263007488 ()

  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Single, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1002-00747
In Commercial Distribution

  • 10873263007478 ()
  • 00873263007471 ()

  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
FC1002

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
34680-00746
In Commercial Distribution

  • 10873263007461 ()
  • 00873263007464 ()

  • Length: 256.4 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
  • Length: 10 Millimeter
34680

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Array, 1 Meg, T=30 for use with frame, STar or MT Drive
FHC, INC.
22670-00745
In Commercial Distribution

  • 10873263007454 ()
  • 00873263007457 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Impedance: Megaohms
  • Length: 10 Millimeter
  • Length: 261.5 Millimeter
22670

  • Depth electrode
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