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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 product FlexPointer 1.5 single use is navigated pointer probe for image guided surgical procedures The instruments are intended as an aid for locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0130041 ()
  • EFIAE0130042 ()
  • EFIAE0130043 ()
  • EFIAE0130044 ()
E 01 3004

  • ENT stereotactic surgery system
Accessory to Cube navigation systems. Device for registration.
Fiagon GmbH
v2
Not in Commercial Distribution

  • EFIAE0114301 ()
E 01 1430

  • ENT stereotactic surgery system
Accessory to Fiagon navigation systems. Device for registration.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0114201 ()
E 01 1420

  • ENT stereotactic surgery system
No Description
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0030010 ()
  • EFIAE0030011 ()
  • 04260759931512 ()

  • Housing for headband ( 86x58mm) elastic tape 49x5mm
  • Weight: 0.036 Kilogram
E 00 3001

  • Multi-purpose stereotactic surgery system
Guide sleeve
MEDENTiKA GmbH
E 43 RT
In Commercial Distribution

  • 04251574843197 ()
  • EMKAE43RT9 ()

  • compatible with Nobel Biocare / NobelReplace®* Tapered
E 43 RT

  • Surgical drill guide, single-use
Drilling sleeve
MEDENTiKA GmbH
E 43 RK
In Commercial Distribution

  • 04251574833846 ()
  • EMKAE43RK9 ()

  • compatible with Nobel Biocare / NobelReplace®* Tapered
E 43 RK

  • Surgical drill guide, single-use
Guide sleeve
MEDENTiKA GmbH
E 42 RT
In Commercial Distribution

  • 04251574843180 ()
  • EMKAE42RT9 ()

  • compatible with Nobel Biocare / NobelReplace®* Tapered
E 42 RT

  • Surgical drill guide, single-use
Drilling sleeve
MEDENTiKA GmbH
E 42 RK
In Commercial Distribution

  • 04251574833839 ()
  • EMKAE42RK9 ()

  • compatible with Nobel Biocare / NobelReplace®* Tapered
E 42 RK

  • Surgical drill guide, single-use
Guide sleeve
MEDENTiKA GmbH
E 41 RT
In Commercial Distribution

  • 04251574843173 ()
  • EMKAE41RT9 ()

  • compatible with Nobel Biocare / NobelReplace®* Tapered
E 41 RT

  • Surgical drill guide, single-use
Drilling sleeve
MEDENTiKA GmbH
E 41 RK
In Commercial Distribution

  • 04251574833822 ()
  • EMKAE41RK9 ()

  • compatible with Nobel Biocare / NobelReplace®* Tapered
E 41 RK

  • Surgical drill guide, single-use
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