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
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660087 ()
30002

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660070 ()
30001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
Not in Commercial Distribution

  • 07640174660063 ()
30000

  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO
In Commercial Distribution

  • 07640174420032 ()


  • Treadmill/elliptical gait rehabilitation system
Robotic-assisted gait trainer
Reha Technology AG
G-EO System
In Commercial Distribution

  • 07640174420018 ()


  • 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
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
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
Refill Kit
Medos International Sàrl
91-4288
In Commercial Distribution

  • 20886704064951 ()
  • 10886704064954 ()
914288

  • Implantable intrathecal infusion pump, programmable
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
SEEG, 16 CONTACT, 2MM & 0.5MM CONTACT DIA., 5MM SPACING AND 13MM BETWEEN CONTACT 9&10, 33MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.1MM DRILL
PMT CORPORATION
2102-16-174
In Commercial Distribution

  • 00650551005506 ()


  • Depth electrode
PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH Copy
PMT CORPORATION
2102-16-185
In Commercial Distribution

  • 00650551002048 ()


  • Depth electrode
PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 29MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH
PMT CORPORATION
2102-16-184
In Commercial Distribution

  • 00650551002031 ()


  • Depth electrode
PLATINUM, 4 CONTACT, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.4MM DRILL, 0.8MM OD, 2MM CONTACT LENGTH, 12.5MM RECORDING DEPTH, 3.5MM SPACING, 60CM MAIN TUBE LENGTH
PMT CORPORATION
2102-04-131
In Commercial Distribution

  • 00650551001881 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 7 X 2MM MACRO CONTACTS, 9 X 75UM MICROWIRE CONTACTS, 30MM RECORDING LENGTH, 0.8MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-09-001
In Commercial Distribution

  • 00650551001799 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACNG AND 37MM BETWEEN CONTACT 9&10 WITH 9-2MM BLANK CONTACTS, 57MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-183
In Commercial Distribution

  • 00650551001430 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 33MM BETWEEN CONTACT 9&10 WITH 9-2MM BLANK CONTACTS, 53MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-182
In Commercial Distribution

  • 00650551001423 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 29MM BETWEEN CONTACT 9&10 WITH 7-2MM BLANK CONTACTS, 49MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-181
In Commercial Distribution

  • 00650551001416 ()


  • Depth electrode
SEEG, 16 CONTACT, 4-2MM & 12-0.5MM CONTACT, NON-STANDARD SPACING AND 25MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 45MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-180
In Commercial Distribution

  • 00650551001409 ()


  • Depth electrode
SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 33MM BETWEEN CONTACT 9&10 WITH 8-2MM BLANK CONTACTS, 66MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-179
In Commercial Distribution

  • 00650551001393 ()


  • Depth electrode
SEEG, 16 CONTACT, 6-2MM & 10-0.5MM CONTACT, NON-STANDARD SPACING AND 27MM BETWEEN CONTACT 9&10 WITH 6-2MM BLANK CONTACTS, 60MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-178
In Commercial Distribution

  • 00650551001386 ()


  • Depth electrode
SEEG, 14 CONTACT, 2MM CONTACT SIZE, 5.33MM CTC SPACING, 71.3MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-14-147
In Commercial Distribution

  • 00650551001201 ()


  • Depth electrode
SEEG, 16 CONTACT, 2MM CONTACT SIZE, 6.53MM CTC SPACING, 100MM RECORDING DEPTH, REMOVABLE STYLET, 2.1MM DRILL
PMT CORPORATION
2102-16-156
In Commercial Distribution

  • 00650551001171 ()


  • Depth electrode
SEEG, 16 CONTACT, 2MM CONTACT SIZE, 6MM CTC SPACING, 92MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-149
In Commercial Distribution

  • 00650551000426 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-177
In Commercial Distribution

  • 00650551000419 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-176
In Commercial Distribution

  • 00650551000402 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL
PMT CORPORATION
2102-16-175
In Commercial Distribution

  • 00650551000396 ()


  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, 17MM RECORDING LENGTH, 5MM SPACING, MINI CONNECTOR
PMT CORPORATION
2102-04-003
In Commercial Distribution

  • 00650551000204 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 8 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 39.5MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-09-32-001
In Commercial Distribution

  • 00650551000150 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 9 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 42.5MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-10-32-002
In Commercial Distribution

  • 00650551000143 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 9 X 1.5MM CONTACTS MACRO CONTACTS, 32 X 40UM MICROWIRE CONTACTS, 50MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-10-32-001
In Commercial Distribution

  • 00650551000136 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 54.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-012
In Commercial Distribution

  • 00650551000129 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 51.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-08-57-011
In Commercial Distribution

  • 00650551000112 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 49.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-010
In Commercial Distribution

  • 00650551000105 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1MM BULLET TIP, 6 X 1.5MM CONTACTS MACRO CONTACTS, 57 X 40UM MICROWIRE CONTACTS, 46.25MM RECORDING LENGTH, 1.27MM DIA., MINI CONNECTOR
PMT CORPORATION
2104-07-57-009
In Commercial Distribution

  • 00650551000099 ()


  • Depth electrode
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
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
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
PUMP 8637-40 SYNCHMED II 40ML EMAN SYMBL
MEDTRONIC, INC.
8637-40
In Commercial Distribution

  • 00643169630512 ()

  • Reservoir Volume 40 mL


  • Implantable intrathecal infusion pump, programmable
PUMP 8637-20 SYNCHMED II 20ML EMAN SYMBL
MEDTRONIC, INC.
8637-20
In Commercial Distribution

  • 00643169630505 ()

  • Reservoir Volume 20 mL


  • Implantable intrathecal infusion pump, programmable
The Optimal-G is a robotics-based powered exercise equipment intended to redevelop muscles and to restore motion to joints during the rehabilitation of a patient recovering from a stroke or other neuromuscular condition. The Optimal-G enables passive and allows active motions of the lower limbs, which are carried out by a single robotic guide. The robotic guide is modular, and designed to be appropriate for use both in the in-patient and outpatient facilities. It incorporates sensors for accurate motion control of the robotic guide and provides measures of patient performance.
MOTORIKA MEDICAL (ISRAEL) LTD
A
In Commercial Distribution

  • 07290017844312 ()
OG01-0000-01

  • Gait rehabilitation system harness
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