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 Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit Manual-afterloading brachytherapy system source delivery procedure kit

• Primary Device ID: 05060116920659
• NIH Device Record Key: 7182fc2f-39f0-4238-9d0f-00e43cc6f4e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraSphere Administration Set
• Version Model Number: OTT-SPE-FP-001
• Company DUNS: 222870839
• Company Name: BIOCOMPATIBLES UK LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btg
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com
• Phone: 1-866-363-3330
• Email: TheraSphereCustomerSupport@btgplc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060116920635 [Primary]
GS1	05060116920642 [Package]; Contains: 05060116920635; Package: Packaging Box [5 Units]; In Commercial Distribution
GS1	05060116920659 [Package]; Contains: 05060116920642; Package: Shipping Box [20 Units]; In Commercial Distribution

FDA Product Code

• NAW: Microspheres Radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-01

On-Brand Devices [TheraSphere Administration Set]

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