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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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CODMAN HAKIM Precision Fixed Pressure Valve Cylindrical Valve with Unitized RICKHAM Reservoir Operating Pressure: 130mm H2O Plus or Minus 10mm H2O (1274 Pa Plus or Minus 98 Pa) High Range Includes: Information Manual
Cerenovus, Inc.
NS0569
Not in Commercial Distribution

  • 10886704045878 ()
NS0569

  • Cerebrospinal fluid shunt valve
CODMAN HAKIM Precision Fixed Pressure Valve Cylindrical Valve with Unitized RICKHAM Reservoir Operating Pressure: 100mm H2O Plus or Minus 10mm H2O (980 Pa Plus or Minus 98 Pa) Medium High Range Includes: Information Manual
Cerenovus, Inc.
NS0568
Not in Commercial Distribution

  • 10886704045861 ()
NS0568

  • Cerebrospinal fluid shunt valve
CODMAN HAKIM Precision Fixed Pressure Valve Cylindrical Valve with Unitized RICKHAM Reservoir Operating Pressure: 70mm H2O Plus or Minus 10mm H2O (686 Pa Plus or Minus 98 Pa) Medium Low Range Includes: Information Manual
Cerenovus, Inc.
NS0567
Not in Commercial Distribution

  • 10886704045854 ()
NS0567

  • Cerebrospinal fluid shunt valve
CODMAN HAKIM Precision Fixed Pressure Valve Cylindrical Valve with Unitized RICKHAM Reservoir Operating Pressure: 40mm H2O Plus or Minus 10mm H2O (392 Pa Plus or Minus 98 Pa) Low Range Includes: Information Manual
Cerenovus, Inc.
NS0566
Not in Commercial Distribution

  • 10886704045847 ()
NS0566

  • Cerebrospinal fluid shunt valve
CODMAN HAKIM Precision Fixed Pressure Valve Cylindrical Valve with Unitized RICKHAM Reservoir Operating Pressure: 10mm H2O Plus or Minus 10mm H2O (98 Pa Plus or Minus 98 Pa) Very Low Range Includes: Information Manual
Cerenovus, Inc.
NS0565
Not in Commercial Distribution

  • 10886704045830 ()
NS0565

  • Cerebrospinal fluid shunt valve
CODMAN HAKIM Precision Fixed Pressure Valve with Large RICKHAM Reservoir (Metal Base) Operating Pressure: 130mm H2O High Range Includes: Peritoneal Catheter 120cm, Ventricular Catheter 14cm, Stylet and Information Manual
Cerenovus, Inc.
NS0560
Not in Commercial Distribution

  • 10886704045816 ()
NS0560

  • Ventriculoperitoneal shunt
CODMAN HAKIM Precision Fixed Pressure Valve with Large RICKHAM Reservoir (Metal Base) Operating Pressure: 70mm H2O Medium Low Range Includes: Peritoneal Catheter 120cm, Ventricular Catheter 14cm, Stylet and Information Manual
Cerenovus, Inc.
NS0559
Not in Commercial Distribution

  • 10886704045809 ()
NS0559

  • Ventriculoperitoneal shunt
CODMAN HAKIM Precision Fixed Pressure Valve with Large RICKHAM Reservoir (Metal Base) Operating Pressure: 40mm H2O Low Range Includes: Peritoneal Catheter 120cm, Ventricular Catheter 14cm, Stylet and Information Manual
Cerenovus, Inc.
NS0558
Not in Commercial Distribution

  • 10886704045793 ()
NS0558

  • Ventriculoperitoneal shunt
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
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