Company Name Brand Name GMDN Term 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
In Commercial Distribution

  • 07640174660100 ()
30004

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

  • 07640174660094 ()
30003

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

  • 07640174660087 ()
30002

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

  • 07640174660070 ()
30001

  • Treadmill/elliptical gait rehabilitation system
No Description
HOCOMA AG
Pro
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
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
Refill Kit
Medos International Sàrl
91-4287
In Commercial Distribution

  • 10886704072072 ()
914287

  • 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
sEEG DEPTH ELECTRODE, 4 MACRO CONTACTS, 12.5 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-04-091-NS
In Commercial Distribution

  • 00650551025412 ()


  • Depth electrode
sEEG DEPTH ELECTRODE, 68.5 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-133-NS
In Commercial Distribution

  • 00650551149989 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-171-NS
In Commercial Distribution

  • 00650551148739 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-170-NS
In Commercial Distribution

  • 00650551148722 ()


  • Depth electrode
PLATINUM sEEG ELECTRODE, 16 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-16-169-NS
In Commercial Distribution

  • 00650551148715 ()


  • Depth electrode
PLATINUM DEPTH ELECTRODE, 4 MACRO CONTACTS, INLINE CONNECTOR, 1 EXIT, 1 LEAD, 2 TAIL, NON-STERILE
PMT CORPORATION
2102-04-145-NS
In Commercial Distribution

  • 00650551148272 ()


  • Depth electrode
PLATINUM DEPTH ELECTRODE, 10 MACRO CONTACTS, INLINE CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-10-036-NS
In Commercial Distribution

  • 00650551148241 ()


  • Depth electrode
PLATINUM DEPTH MICROWIRE ELECTRODE, 8 MACRO CONTACTS, 16 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 3 LEAD
PMT CORPORATION
2104-08-16-006
In Commercial Distribution

  • 00650551148173 ()


  • Depth electrode
PLATINUM MICROWIRE ELECTRODE, 8 MACRO CONTACTS 8 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2104-08-08-001
In Commercial Distribution

  • 00650551147947 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 14 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-14-149
In Commercial Distribution

  • 00650551147657 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 12 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-12-149
In Commercial Distribution

  • 00650551147640 ()


  • Depth electrode
PLATINUM MICROWIRE DEPTH ELECTRODE, 10 MICRO CONTACTS, MINI CONNECTOR, NON-STERILE
PMT CORPORATION
2104-00-10-004-NS
In Commercial Distribution

  • 00650551147473 ()


  • Depth electrode
PLATINUM DEPTH ELECTRODE, 10 MACRO CONTACTS, MINI CONNECTOR, MACRO/MICRO JUNCTION. NON-STERILE
PMT CORPORATION
2102-10-002-NS
In Commercial Distribution

  • 00650551147466 ()


  • Depth electrode
PLATINUM DEPTH ELECTRODE, 8 MACRO CONTACTS, MINI CONNECTOR, MACRO/MICRO JUNCTION, NON-STERILE
PMT CORPORATION
2102-08-002-NS
In Commercial Distribution

  • 00650551147459 ()


  • Depth electrode
PLATINUM DEPTH ELECTRODE, 6 MACRO CONTACTS, MINI CONNECTOR, MACRO/MICRO JUNCTION, NON-STERILE
PMT CORPORATION
2102-06-002-NS
In Commercial Distribution

  • 00650551147442 ()


  • Depth electrode
PLATINUM DEPTH ELECTRODE, 4 MACRO CONTACTS, MINI CONNECTOR, MICRO/MACRO JUNCTIONS, NON STERILE
PMT CORPORATION
2102-04-002-NS
In Commercial Distribution

  • 00650551147435 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-173
In Commercial Distribution

  • 00650551147411 ()


  • Depth electrode
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