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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 Yttrium-90 Glass Microspheres 8.5 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
TheraSphere Yttrium-90 Glass Microspheres 7.5 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
TheraSphere Yttrium-90 Glass Microspheres 6.5 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
TheraSphere Yttrium-90 Glass Microspheres 6.0 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
TheraSphere Yttrium-90 Glass Microspheres 5.5 GBq Dose (US Commercial)
BIOCOMPATIBLES UK LTD
OTT-SPE-FP-700 (990700.SPE)
In Commercial Distribution



  • Manual brachytherapy source, permanent implant
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
Dental Implant System (DIOACS)
DENTIS CO. ,LTD
DIOACS
In Commercial Distribution



  • Dental prosthesis/implant abutment screw
obelisc lateral end piece, blue, length 55 mm, angle 15°
Ulrich GmbH & Co. KG
CS 2916-15
In Commercial Distribution

CS 2916-15

  • Vertebral body prosthesis
obelisc lateral end piece, blue, length 55 mm, angle 10°
Ulrich GmbH & Co. KG
CS 2916-10
In Commercial Distribution

CS 2916-10

  • Vertebral body prosthesis
obelisc lateral end piece, blue, length 55 mm, angle 5°
Ulrich GmbH & Co. KG
CS 2916-05
In Commercial Distribution

CS 2916-05

  • Vertebral body prosthesis
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