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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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For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes
DiaSpect Medical GmbH
90B.0012
In Commercial Distribution

  • 04048534001717 ()
  • 04048534001564 ()


  • Total haemoglobin (totHb) IVD, control
For the verification of the precision and accuracy of DiaSpect Hemoglobin Analyzer and DiaSpect Hemoglobin Cuvettes
DiaSpect Medical GmbH
90B.0011
In Commercial Distribution

  • 04048534001700 ()
  • 04048534001557 ()


  • Total haemoglobin (totHb) IVD, control
For the quantitative determination of hemoglobin in whole blood.
DiaSpect Medical GmbH
90C.0001
In Commercial Distribution

  • 04048534001694 ()
  • 04048534001540 ()
  • 04048534001687 ()


  • Haemoglobin analyser IVD, point-of-care
Okti 128 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 128
In Commercial Distribution

  • 09342451002228 ()
8029-0004-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder
Okti 64 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 64
In Commercial Distribution

  • 09342451002211 ()
8029-0003-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder
Okti 32 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 32
In Commercial Distribution

  • 09342451002204 ()
8029-0002-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder
3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded (16 + 2 shades). Suitable for single crowns and/or bridges consisting of up to 16 units. 4-point bending strength: 1200 MPa (typical value)
DOCERAM medical ceramics GmbH
Pearl Shaded D4
In Commercial Distribution

  • EDMC32773024240 ()

  • Height: 24 Millimeter
  • Length: 24 Millimeter
  • Width: 24 Millimeter
3277302424

  • Dental appliance fabrication material, ceramic
3Y-TZP zirconium dioxide, pre-sintered white-fired condition. High translucent, pre-shaded (16 + 2 shades). Suitable for single crowns and/or bridges consisting of up to 16 units. 4-point bending strength: 1200 MPa (typical value)
DOCERAM medical ceramics GmbH
Pearl Shaded D3
In Commercial Distribution

  • EDMC32763024240 ()

  • Height: 24 Millimeter
  • Length: 24 Millimeter
  • Width: 24 Millimeter
3276302424

  • Dental appliance fabrication material, ceramic
The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.
Dental Direkt GmbH
24x24x24 C2
In Commercial Distribution

  • EDDI32723024241 ()

  • Length: 24 Millimeter
  • Height: 24 Millimeter
  • Width: 24 Millimeter
3272302424

  • Dental appliance fabrication material, ceramic
The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.
Dental Direkt GmbH
24x24x24 C1
In Commercial Distribution

  • EDDI32713024241 ()

  • Length: 24 Millimeter
  • Height: 24 Millimeter
  • Width: 24 Millimeter
3271302424

  • Dental appliance fabrication material, ceramic
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