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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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Clear Guide VisiMARKER II - B201CGVM20

The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM2
In Commercial Distribution

  • B201CGVM20 ()
  • B201CGVM21 ()
  • B201CGVM23 ()
  • B201CGVM22 ()
CG-VM2

  • Imaging lesion localization marker, external, single-use

Clear Guide VisiMARKER - B201CGVM0

The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.
CLEAR GUIDE MEDICAL, INC.
CGVM
In Commercial Distribution

  • B201CGVM2 ()
  • B201CGVM1 ()
  • B201CGVM0 ()
  • B201CGVM3 ()


  • Imaging lesion localization marker, external, single-use

NavitrackER - 00889024304239

No Description
Orthosoft Inc
20-8000-000-08
In Commercial Distribution

  • 00889024304239 ()
  • 00889024466340 ()
20-8000-000-08

  • Imaging lesion localization marker, external, single-use

NavitrackER - 00889024304222

No Description
Orthosoft Inc
20-8000-000-07
In Commercial Distribution

  • 00889024304222 ()
  • 00889024466333 ()
20-8000-000-07

  • Imaging lesion localization marker, external, single-use

TruDi NAV Cable - 20705031245867

TruDi NAV Cable - 1PK
ACCLARENT, INC.
TDNC001Z
In Commercial Distribution

  • 20705031245867 ()
TDNC001Z

  • Electromagnetic/optical surgical navigation device tracking system

NDI Passive Spheres - 00805832020031

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 4 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres.
Northern Digital Inc
8801054
In Commercial Distribution

  • 00805832020031 ()
  • 20805832020035 ()
8801054

  • Imaging lesion localization marker, external, single-use

NDI Passive Spheres - 00805832020017

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 12 spheres.
Northern Digital Inc
8801051
In Commercial Distribution

  • 00805832020017 ()
  • 20805832020011 ()
8801051

  • Imaging lesion localization marker, external, single-use

NDI Passive Sphere - 00805832070043

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There is 1 tray-in-pouch for a total of 5 spheres.
Northern Digital Inc
8801085
In Commercial Distribution

  • 00805832070043 ()
8801085

  • Imaging lesion localization marker, external, single-use

NDI Passive Sphere - 00805832070036

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 5 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 60 spheres.
Northern Digital Inc
8801075
In Commercial Distribution

  • 20805832070030 ()
  • 00805832070036 ()
8801075

  • Imaging lesion localization marker, external, single-use

NDI Passive Sphere - 00805832070029

Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 4 spheres per tray in a pouch. There are 12 tray-in-pouches for a total of 48 spheres.
Northern Digital Inc
8801074
In Commercial Distribution

  • 20805832070023 ()
  • 00805832070029 ()
8801074

  • Imaging lesion localization marker, external, single-use
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