TheraSphere Administration Set

GUDID 05060116920659

Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres

BIOCOMPATIBLES UK LTD

Manual-afterloading brachytherapy system source delivery procedure kit
Primary Device ID05060116920659
NIH Device Record Key7182fc2f-39f0-4238-9d0f-00e43cc6f4e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraSphere Administration Set
Version Model NumberOTT-SPE-FP-001
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
GS105060116920635 [Primary]
GS105060116920642 [Package]
Contains: 05060116920635
Package: Packaging Box [5 Units]
In Commercial Distribution
GS105060116920659 [Package]
Contains: 05060116920642
Package: Shipping Box [20 Units]
In Commercial Distribution

FDA Product Code

NAWMicrospheres Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-03
Device Publish Date2018-11-01

On-Brand Devices [TheraSphere Administration Set]

05060116920659Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres
05060116920253Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres

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