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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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Optune - 07290107981682

No Description
NOVOCURE INC.
THF9000
Not in Commercial Distribution

  • 07290107981682 ()
90051

  • Alternating electric field antimitotic cancer treatment system generator

Optune Porteable Battery Rack - 07290107981668

No Description
NOVOCURE INC.
PBR9000
Not in Commercial Distribution

  • 07290107981668 ()
90039

  • Alternating electric field antimitotic cancer treatment system generator

Optune Porrtable Battery Charger - 07290107981651

No Description
NOVOCURE INC.
ICH9000
Not in Commercial Distribution

  • 07290107981651 ()
90023

  • Alternating electric field antimitotic cancer treatment system generator

Portable Battery for Optune - 07290107981644

No Description
NOVOCURE INC.
IBH9000
Not in Commercial Distribution

  • 07290107981644 ()
90019

  • Alternating electric field antimitotic cancer treatment system generator

Connection Cable for Optune - 07290107981637

Connection Cable unit
NOVOCURE INC.
CAD9000
Not in Commercial Distribution

  • 07290107981637 ()
90009

  • Alternating electric field antimitotic cancer treatment system generator

Optune Battery Charger - 07290107981606

No Description
Novocure GmbH
ICH9100
In Commercial Distribution

  • 07290107981606 ()
ICH9100US

  • Alternating electric field antimitotic cancer treatment system generator

Battery for Optune - 07290107981590

No Description
Novocure GmbH
IBH9100
Not in Commercial Distribution

  • 07290107981590 ()
IBH9100US

  • Alternating electric field antimitotic cancer treatment system generator

NovoTAL Software for Array Mapping - 07290107981576

No Description
Novocure GmbH
NovoTAL Software
Not in Commercial Distribution

  • 07290107981576 ()
90094

  • Alternating electric field antimitotic cancer treatment system generator

Device Bag for the Optune - 07290107981569

No Description
Novocure GmbH
BAG 9000_GRAY
Not in Commercial Distribution

  • 07290107981569 ()
90002

  • Alternating electric field antimitotic cancer treatment system generator

Optune - 07290107981538

No Description
Novocure GmbH
THF9000
Not in Commercial Distribution

  • 07290107981538 ()
90051

  • Alternating electric field antimitotic cancer treatment system generator
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