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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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POLARIS ADJUSTABLE VALVE 140
SOPHYSA
SPV-140
In Commercial Distribution

  • 03760124131260 ()


  • Cerebrospinal fluid shunt valve
POLARIS ADJUSTABLE VALVE/5 PRESS.
SOPHYSA
SPV
In Commercial Distribution

  • 03760124131253 ()


  • Cerebrospinal fluid shunt valve
SOPHY MINI PROG.VALVE/8 PRESS. BURR HOLE
SOPHYSA
SM8B
In Commercial Distribution

  • 03760124131239 ()


  • Cerebrospinal fluid shunt valve
SOPHY MINI PROG.VALVE/8.PRESS. ANTICHAMBER
SOPHYSA
SM8A
In Commercial Distribution

  • 03760124131215 ()


  • Cerebrospinal fluid shunt valve
SOPHY MINI PROG.VALVE/8PRESS.
SOPHYSA
SM8
In Commercial Distribution

  • 03760124131093 ()


  • Cerebrospinal fluid shunt valve
The Inspire® Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG) for treatment of obstructive sleep apnea.
Inspire Medical Systems, Inc.
900-014-005
In Commercial Distribution

  • 10810098650301 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-003
In Commercial Distribution

  • 10810098650295 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
M.BLUE PLUS VALVE
Aesculap AG
FX804T
In Commercial Distribution

  • 04041906504793 ()

  • Pressure rating horiz. (cmH2O) : 0.000 - 20.000 CWS
FX804T

  • Cerebrospinal fluid shunt valve
M.BLUE 15 VALVE W/PERITONEAL CATHETER
Aesculap AG
FX808T
In Commercial Distribution

  • 04041906504465 ()

  • Pressure rating horiz. (cmH2O) : 15.000 CWS
FX808T

  • Cerebrospinal fluid shunt valve
M.BLUE 5 VALVE W/PERITONEAL CATHETER
Aesculap AG
FX806T
In Commercial Distribution

  • 04041906504441 ()

  • Pressure rating horiz. (cmH2O) : 5.000 CWS
FX806T

  • Cerebrospinal fluid shunt valve
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