TheraSphere Y90 Glass Microspheres 19.5 GBq

GUDID 05060116920628

TheraSphere Yttrium-90 Glass Microspheres 19.5 GBq Dose

BIOCOMPATIBLES UK LTD

Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant
Primary Device ID05060116920628
NIH Device Record Key9d56300f-b5ed-4b47-baeb-0ec264920919
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraSphere Y90 Glass Microspheres 19.5 GBq
Version Model Number990700.SPE
Company DUNS222870839
Company NameBIOCOMPATIBLES UK LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btg
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com
Phone1-866-363-3330
EmailTheraSphereCustomerSupport@btgplc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060116920628 [Primary]

FDA Product Code

NAWMicrospheres Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-24

Devices Manufactured by BIOCOMPATIBLES UK LTD

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05060116921373 - TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 3.0 GBq Dose (US Commercial)
05060116921380 - TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 3.5 GBq Dose (US Commercial)
05060116921397 - TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 4.0 GBq Dose (US Commercial)
05060116921403 - TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 4.5 GBq Dose (US Commercial)
05060116921410 - TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 5.0 GBq Dose (US Commercial)
05060116921427 - TheraSphere Y90 Glass Microspheres 5.5 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 5.5 GBq Dose (US Commercial)
05060116921434 - TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial)2020-06-29 TheraSphere Yttrium-90 Glass Microspheres 6.0 GBq Dose (US Commercial)

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