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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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TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial) - 05060116921410

TheraSphere Yttrium-90 Glass Microspheres 5.0 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant

TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial) - 05060116921403

TheraSphere Yttrium-90 Glass Microspheres 4.5 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant

TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial) - 05060116921397

TheraSphere Yttrium-90 Glass Microspheres 4.0 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant

TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial) - 05060116921380

TheraSphere Yttrium-90 Glass Microspheres 3.5 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant

TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial) - 05060116921373

TheraSphere Yttrium-90 Glass Microspheres 3.0 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant

TheraSphere Administration Set - 05060116920635

Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-001
In Commercial Distribution

  • 05060116920659 ()
  • 05060116920642 ()
  • 05060116920635 ()


  • Manual-afterloading brachytherapy system source delivery procedure kit

TheraSphere Y90 Glass Microspheres 19.5 GBq - 05060116920628

TheraSphere Yttrium-90 Glass Microspheres 19.5 GBq Dose
BIOCOMPATIBLES UK LTD
990700.SPE
Not in Commercial Distribution

  • 05060116920628 ()


  • Manual brachytherapy source, permanent implant

TheraSphere Y90 Glass Microspheres 19.0 GBq - 05060116920611

TheraSphere Yttrium-90 Glass Microspheres 19.0 GBq Dose
BIOCOMPATIBLES UK LTD
990700.SPE
Not in Commercial Distribution

  • 05060116920611 ()


  • Manual brachytherapy source, permanent implant

TheraSphere Y90 Glass Microspheres 18.5 GBq - 05060116920604

TheraSphere Yttrium-90 Glass Microspheres 18.5 GBq Dose
BIOCOMPATIBLES UK LTD
990700.SPE
Not in Commercial Distribution

  • 05060116920604 ()


  • Manual brachytherapy source, permanent implant

TheraSphere Y90 Glass Microspheres 18.0 GBq - 05060116920598

TheraSphere Yttrium-90 Glass Microspheres 18.0 GBq Dose
BIOCOMPATIBLES UK LTD
990700.SPE
Not in Commercial Distribution

  • 05060116920598 ()


  • Manual brachytherapy source, permanent implant
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