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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 SAMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-400-00
In Commercial Distribution

  • B815SA400000 ()
SA-400-00

  • Haemodialysis blood tubing set, single-use
The SAMI Hemofiltration Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
SA-300-00
In Commercial Distribution

  • B815SA300000 ()
SA-300-00

  • Haemodialysis blood tubing set, single-use
The DIMI RRT Cassette is provided sterile, single use only, and has a non-toxic, non-pyrogenic fluid path. The package is sterile if the package is intact, undamaged, and protective caps are secure. The cassette tubing set is a single line set including venous and arterial blood paths and is provided as a single unit in a sterile pouch.
Dialco Medical Inc
DI-400-00
In Commercial Distribution

  • B815DI400000 ()
DI-400-00

  • Haemodialysis blood tubing set, single-use
No Description
RIMSA P. LONGONI SRL
Z400460-4
In Commercial Distribution

  • B880Z40046040 ()


  • Medical equipment handle cover, reusable
No Description
RIMSA P. LONGONI SRL
Z400349-4
In Commercial Distribution

  • B880Z40034940 ()


  • Medical equipment handle cover, reusable
No Description
RIMSA P. LONGONI SRL
Z400307-4
In Commercial Distribution

  • B880Z40030740 ()


  • Medical equipment handle cover, reusable
The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail. The adhesive pad is an important accessory of the Localizer Adhesive pad.
Fiagon GmbH
1
In Commercial Distribution

  • EFIAE0122021 ()
  • EFIAE0122020 ()

  • Weight: 0.025 Kilogram
  • Housing 25mmX8mm


  • Multi-purpose stereotactic surgery system
The product Localizer Headband is a product variant of a patient reference localisator. for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, the users receive a training. The operator, i.e., the person or facility that is responsible for the use and service of the system, must ensure that all users of the system receive an adequate introduction into the system in accordance with valid laws and regulations. An operator is everyone who uses the system. The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail.
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0122001 ()
  • EFIAE0122000 ()

  • Weight: 0.035 Kilogram
  • Height: 15 Millimeter
  • Width: 30 Millimeter
  • Length: 45 Millimeter


  • Multi-purpose stereotactic surgery system
The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument is indicated for any medical condition in which the use ofstereotactic 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

  • EFIAE0121081 ()
  • EFIAE0121080 ()

  • Olive tip: Ø 4,3 Millimeter
  • Outer Diameter: 3 Millimeter
  • Length: 130 Millimeter


  • Multi-purpose stereotactic surgery system
The product is a variant of a navigated suction instrument for image guided surgical procedures .The instrument is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument is indicated for any medical condition in which the use ofstereotactic 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

  • EFIAE0121071 ()
  • EFIAE0121070 ()

  • Length: 100 Millimeter
  • Outer Diameter: 3 Millimeter
  • Olive tip: Ø 4,3 Millimeter


  • Multi-purpose stereotactic surgery system
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