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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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No Description
Roche Diagnostics GmbH
05917824160
In Commercial Distribution

  • 04015630927807 ()
05917824160

  • Multiple-type clinical chemistry analyte profile IVD, control
The product, PointerShell 5 mm is a product variant for the navigation of shavers or surgical instruments without motor in the handle and are referred to as ,PointerShell. The instruments are intended as an aid for precisely 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
Not in Commercial Distribution

  • EFIAE0129011 ()
  • EFIAE0129010 ()


  • Multi-purpose stereotactic surgery system
No Description
AMI Agency for Medical Innovations GmbH
ESI1530
Not in Commercial Distribution

  • EAMIESI15300 ()

  • Shaft Length: 420 Millimeter
  • Outer Diameter: 5 Millimeter
ESI1530

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESI1520
Not in Commercial Distribution

  • EAMIESI15200 ()

  • Shaft Length: 340 Millimeter
  • Outer Diameter: 5 Millimeter
ESI1520

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESI1510
Not in Commercial Distribution

  • EAMIESI15100 ()

  • Outer Diameter: 5 Millimeter
  • Shaft Length: 250 Millimeter
ESI1510

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESH1530
Not in Commercial Distribution

  • EAMIESH15300 ()

  • Shaft Length: 420 Millimeter
  • Outer Diameter: 5 Millimeter
ESH1530

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESH1520
Not in Commercial Distribution

  • EAMIESH15200 ()

  • Shaft Length: 340 Millimeter
  • Outer Diameter: 5 Millimeter
ESH1520

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
ESH1510
Not in Commercial Distribution

  • EAMIESH15100 ()

  • Shaft Length: 250 Millimeter
  • Outer Diameter: 5 Millimeter
ESH1510

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
EAS1530
Not in Commercial Distribution

  • EAMIEAS15300 ()

  • Shaft Length: 420 Millimeter
  • Outer Diameter: 5 Millimeter
EAS1530

  • Electrosurgical handpiece, reusable
No Description
AMI Agency for Medical Innovations GmbH
EAS1520
Not in Commercial Distribution

  • EAMIEAS15200 ()

  • Shaft Length: 340 Millimeter
  • Outer Diameter: 5 Millimeter
EAS1520

  • Electrosurgical handpiece, reusable
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