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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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The Instrument clip EM 4 mm provides a way to track the location of compatible conventional surgical instruments. After performing a calibration step the tip of the conventional instrument can be navigated. The clip connects to the Hybrid Navigation Unit EM via an integrated cable. The clip is provided non-sterile and is intended to be sterilized by the user. The Instrument clip EM 4 mm is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1085400 ()
U1 085 40

  • Electromagnetic surgical navigation device tracking system
The Universal tracker EM provides a way to track the location of compatible conventional surgical instruments. It is mounted on the conventional instrument with a suitable instrument clamp and calibrated to navigate the tip of instrument. The Universal tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Universal tracker EM is provided non-sterile and is intended to be sterilized by the user. The Universal tracker EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1046020 ()
U1 046 02

  • Electromagnetic surgical navigation device tracking system
The Suction tube Frazier EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables. Suction tubes are provided non-sterile and is intended to be sterilized by the user. Suction tubes are reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1030110 ()
U1 030 11

  • Electromagnetic surgical navigation device tracking system
The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to navigate within the anatomical space. The location of the instrument is referenced relative to a patient tracker that is attached to the patient. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable. The Precision Pointer EM is provided non-sterile and is intended to be sterilized by the user. The Precision Pointer EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1029010 ()
U1 029 01

  • Electromagnetic surgical navigation device tracking system
The Instrument port is a sterile handling port for the other EM navigated instruments. The Instrument port connects to the Hybrid Navigation Unit EM on one side and to an EM navigated instrument on the other. The Instrument port is provided non-sterile and is intended to be sterilized by the user. The Instrument port is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1049010 ()
U1 049 01

  • Electromagnetic surgical navigation device tracking system
The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Calibration body EM is provided non-sterile and is intended to be sterilized by the user. The Calibration body EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1038020 ()
U1 038 02

  • Electromagnetic surgical navigation device tracking system
The Endoscope tracker EM provides a way to track the location of compatible conventional rigid endoscopes. The location of the instrument is referenced relative to a patient tracker. The Endoscope tracker EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Endoscope tracker EM is provided non-sterile and is intended to be sterilized by the user. The Endoscope tracker EM is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1037020 ()
U1 037 02

  • Electromagnetic surgical navigation device tracking system
The Suction tube Eicken EM provides an electromagnetically tracked instrument that is used to navigate within the patient anatomy during surgery. The location of the instrument is referenced relative to a patient tracker that is affixed to the patient’s anatomy. The navigated suction tube connects to the Hybrid Navigation Unit EM via integrated cables. Suction tubes are provided non-sterile and are intended to be sterilized by the user. Suction tubes are reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1030120 ()
U1 030 12

  • Electromagnetic surgical navigation device tracking system
The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register the patient anatomy. The location of the instrument is referenced relative to a patient tracker affixed to the patient’s anatomy. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable. The Precision Pointer EM-D is provided non-sterile and is intended intended for high-level disinfection only. It is intended to be used prior to surgical draping while the patient environment is not covered under sterile drape. The Registration Pointer EM-D is reusable.
Scopis GmbH
1.0
In Commercial Distribution

  • B057U1029030 ()
U1 029 03

  • Electromagnetic surgical navigation device tracking system
No Description
ORANGE SURGICAL INSTRUMENTS, LLC
SD9394301
Not in Commercial Distribution

  • B35400 ()
  • B382SD93943014 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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