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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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No Description
Biomet Orthopedics, LLC
010000985
In Commercial Distribution

  • 00880304989092 ()

  • 36MM HEAD SIZE G LINER SIZE
010000985

  • Constrained polyethylene acetabular liner
No Description
Biomet Orthopedics, LLC
010000984
In Commercial Distribution

  • 00880304989085 ()

  • 36MM HEAD SIZE F LINER SIZE
010000984

  • Constrained polyethylene acetabular liner
No Description
Biomet Orthopedics, LLC
010000983
In Commercial Distribution

  • 00880304989078 ()

  • 36MM HEAD SIZE E LINER SIZE
010000983

  • Constrained polyethylene acetabular liner
No Description
Biomet Orthopedics, LLC
010000982
In Commercial Distribution

  • 00880304989061 ()

  • 36MM HEAD SIZE D LINER SIZE
010000982

  • Constrained polyethylene acetabular liner
ANTENNA 37092 EXT ULTRA US MKT
MEDTRONIC, INC.
37092
In Commercial Distribution

  • 00613994348661 ()


  • Multiple active implantable device programmer
ANTENNA 37092 ITREL4 W/OUT INTERCEPT
MEDTRONIC, INC.
37092
In Commercial Distribution

  • 00643169108196 ()


  • Multiple active implantable device programmer
ANTENNA 37092 SENSOR W/OUT INTERCEPT
MEDTRONIC, INC.
37092
In Commercial Distribution

  • 00613994747044 ()


  • Multiple active implantable device programmer
ANTENNA 37092 RX1 EXTNL,TELEMETRY ONLY
MEDTRONIC, INC.
37092
In Commercial Distribution

  • 00885074291475 ()


  • Multiple active implantable device programmer
ANTENNA 37092 MGU EXTERNAL TELEMETRY
MEDTRONIC, INC.
37092
In Commercial Distribution

  • 00885074554501 ()


  • Multiple active implantable device programmer
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
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