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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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AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly - 00810020440140

For Collection of Platelets with Optional Plasma. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2354G
In Commercial Distribution

  • 00810020440140 ()
  • 10810020440147 ()
4R2354G

  • Apheresis system tubing set

Aurora Plasmapheresis System Software Version 2.1 - 00810020440003

Aurora Plasmapheresis System Software Version 2.1
Fresenius Kabi AG
SW 2.1
In Commercial Distribution

  • 00810020440003 ()
  • 10810020440000 ()


  • Apheresis system

Tropocells - 07290015874380

No Description
ESTAR TECHNOLOGIES LTD
ESTSN1650
In Commercial Distribution

  • 07290015874380 ()
ESTSN1650

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874359

No Description
ESTAR TECHNOLOGIES LTD
521254US
In Commercial Distribution

  • 07290015874359 ()
521254US

  • Haematological concentrate system preparation kit, platelet concentration

Eclipse PRP, Tropocells - 07290015874328

No Description
ESTAR TECHNOLOGIES LTD
26754E
In Commercial Distribution

  • 07290015874328 ()
26754E

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874311

No Description
ESTAR TECHNOLOGIES LTD
ESTSN1690
In Commercial Distribution

  • 07290015874311 ()
ESTSN1690

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874229

No Description
ESTAR TECHNOLOGIES LTD
1253VTSF10
Not in Commercial Distribution

  • 07290015874229 ()
1253VTSF10

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874137

No Description
ESTAR TECHNOLOGIES LTD
14992905GLA
In Commercial Distribution

  • 07290015874137 ()
14992905GLA

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells - 07290015874120

No Description
ESTAR TECHNOLOGIES LTD
12991402GLA
In Commercial Distribution

  • 07290015874120 ()
12991402GLA

  • Haematological concentrate system preparation kit, platelet concentration

Tropocells®, Eclipse PRP, Healeon PRP - 07290015874014

No Description
ESTAR TECHNOLOGIES LTD
12531102GLVAS
In Commercial Distribution

  • 07290015874014 ()
12531102GLVAS

  • Haematological concentrate system preparation kit, platelet concentration
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