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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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VALVE 42106 STANDARD HIGH
MEDTRONIC PS MEDICAL, INC.
42106
In Commercial Distribution

  • 00643169073562 ()

  • High Pressure


  • Cerebrospinal fluid shunt valve
ASSY 46814 DELTA SHUNT SMALL P/L 2
MEDTRONIC PS MEDICAL, INC.
46814
In Commercial Distribution

  • 00643169073524 ()

  • Performance Level 2.0
  • Length: 60.0 Centimeter
  • Length: 90.0 Centimeter


  • Ventriculoperitoneal shunt
ASSY 46823 DELTA SHUNT REG LEV 1.5
MEDTRONIC PS MEDICAL, INC.
46823
In Commercial Distribution

  • 00643169073500 ()

  • Performance Level 1.5
  • Length: 60.0 Centimeter
  • Length: 90.0 Centimeter


  • Ventriculoperitoneal shunt
ASSY 46824 DELTA SHUNT REG P/L 2
MEDTRONIC PS MEDICAL, INC.
46824
In Commercial Distribution

  • 00643169073494 ()

  • Length: 60.0 Centimeter
  • Length: 90.0 Centimeter
  • Performance Level 2.0


  • Ventriculoperitoneal shunt
The Model 2740C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.
Inspire Medical Systems, Inc.
900-018-001
In Commercial Distribution

  • 00855728005994 ()
2740C

  • Implantable sleep apnoea treatment system, respiration-sensing
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.
900-014-003
In Commercial Distribution

  • 00855728005949 ()
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.
900-013-001
In Commercial Distribution

  • 00855728005796 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
No Description
Synapse Biomedical, Inc.
21-0017-99
In Commercial Distribution

  • 00852184003144 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, active
SHUNT 27643L ASSY SM PCATH130CM LOW
MEDTRONIC PS MEDICAL, INC.
27643L
In Commercial Distribution

  • 00681490533843 ()

  • Length: 130.0 Centimeter
  • Low Pressure


  • Ventriculoperitoneal shunt
SHUNT 24133-2 CSF-DELTA CHMBR PERIT 2.0
MEDTRONIC PS MEDICAL, INC.
24133-2
In Commercial Distribution

  • 00613994965882 ()

  • Performance Level 2.0
  • Length: 90.0 Centimeter


  • Ventriculoperitoneal shunt
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