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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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DeRoyal - 00749756847865

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672
In Commercial Distribution

  • 50749756847860 ()
  • 00749756847865 ()
M2672

  • Gait rehabilitation system harness

DeRoyal - 00749756846462

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2656
In Commercial Distribution

  • 00749756846462 ()
M2656

  • Gait rehabilitation system harness

DeRoyal - 00749756735209

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5166-B
In Commercial Distribution

  • 50749756735204 ()
  • 00749756735209 ()
M5166-B

  • Gait rehabilitation system harness

DeRoyal - 00749756678032

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164
In Commercial Distribution

  • 00749756678032 ()
M5164

  • Gait rehabilitation system harness

DeRoyal - 00749756677776

Gait Belt, Heavy Duty
DEROYAL INDUSTRIES, INC.
M5165
In Commercial Distribution

  • 00749756677776 ()
M5165

  • Gait rehabilitation system harness

DeRoyal - 00749756613637

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5168
In Commercial Distribution

  • 00749756613637 ()
M5168

  • Gait rehabilitation system harness

DeRoyal - 00749756999274

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5164-YL
In Commercial Distribution

  • 50749756999279 ()
  • 00749756999274 ()
M5164-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756977937

Kit W/Blanket and Gait Belt
DEROYAL INDUSTRIES, INC.
MK3045-UBLG
In Commercial Distribution

  • 50749756977932 ()
  • 00749756977937 ()
MK3045-UBLG

  • Gait rehabilitation system harness

DeRoyal - 00749756951784

GAIT BELT, HEAVY DUTY
DEROYAL INDUSTRIES, INC.
M2672-B
In Commercial Distribution

  • 50749756951789 ()
  • 00749756951784 ()
M2672-B

  • Gait rehabilitation system harness

DeRoyal - 00749756947657

GAIT BELT, WIPEABLE
DEROYAL INDUSTRIES, INC.
M5168-YL
In Commercial Distribution

  • 00749756947657 ()
M5168-YL

  • Gait rehabilitation system harness

DeRoyal - 00749756884440

Gait Belt, Wipable
DEROYAL INDUSTRIES, INC.
M5168-Y
In Commercial Distribution

  • 00749756884440 ()
M5168-Y

  • Gait rehabilitation system harness

DeRoyal - 00749756866309

Gait Belt, Heavy DutyTiger Teeth Buckle, 2 In X 70 In
DEROYAL INDUSTRIES, INC.
M2572
In Commercial Distribution

  • 50749756866304 ()
  • 00749756866309 ()
M2572

  • Gait rehabilitation system harness

DeRoyal - 00749756861274

GAIT BELT
DEROYAL INDUSTRIES, INC.
M2660
In Commercial Distribution

  • 50749756861279 ()
  • 00749756861274 ()
M2660

  • Gait rehabilitation system harness

Prometra Programmable Pump - 00810335020242

Prometra II 40ml Programmable Pump
Flowonix Medical, Inc.
16827
In Commercial Distribution

  • 00810335020242 ()


  • Implantable intrathecal infusion pump, programmable

Prometra II Pump - 00810335020228

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

Prometra Programmable Pump - 00810335020082

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

microTargeting™ Electrode - 10873263009205

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 - 10873263008680

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 - 10873263008635

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™ Electrode - 10873263007997

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™ Electrode - 10873263007973

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™ Electrode - 10873263007959

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™ Electrode - 10873263007935

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 Electrode - 10873263007911

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 Electrode - 10873263007898

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™ Electrodes - 10873263007553

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™ Electrodes - 10873263007522

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™ Electrode - 10873263007515

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™ Electrode - 10873263007508

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™ Electrode - 10873263007492

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
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