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
ALPHA OMEGA ENGINEERING CO. LTD.
Non-Shielded
In Commercial Distribution

  • 17290114061534 ()
  • 07290114061537 ()
STR-222291-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega system
In Commercial Distribution

  • 07290114061506 ()
NOM-000000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-5.5mm
In Commercial Distribution

  • 07290114060875 ()
190-000117-11

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type N-4 mm
In Commercial Distribution

  • 07290114060851 ()
190-000117-15

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type K
In Commercial Distribution

  • 07290114060844 ()
190-000117-14

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type D
In Commercial Distribution

  • 07290114060820 ()
190-000117-12

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type H
In Commercial Distribution

  • 07290114060554 ()
190-000117-09

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type F
In Commercial Distribution

  • 07290114060547 ()
190-000117-08

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type I
In Commercial Distribution

  • 07290114060530 ()
190-000117-07

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type M
In Commercial Distribution

  • 07290114060523 ()
190-000117-05

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type L-4mm
In Commercial Distribution

  • 07290114060516 ()
190-000117-04

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type J
In Commercial Distribution

  • 07290114060509 ()
190-000117-03

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type G
In Commercial Distribution

  • 07290114060493 ()
190-000117-02

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Plug Type B
In Commercial Distribution

  • 07290114060486 ()
190-000117-01

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

  • 00749756613637 ()
M5168

  • 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
No Description
Bird & Cronin, LLC
08146722
In Commercial Distribution

  • 00610570022618 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146602
In Commercial Distribution

  • 00610570022335 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146542
In Commercial Distribution

  • 00610570022236 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146452
In Commercial Distribution

  • 00610570021918 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08140480
In Commercial Distribution

  • 00610570002801 ()


  • Gait rehabilitation system harness
No Description
Bird & Cronin, LLC
08146882
In Commercial Distribution

  • 00610570022823 ()


  • Gait rehabilitation system harness
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