TheraSphere Y90 Glass Microspheres 13.5 GBq

GUDID 05060116920512

TheraSphere Yttrium-90 Glass Microspheres 13.5 GBq Dose

BIOCOMPATIBLES UK LTD

Manual brachytherapy source, permanent implant

• Primary Device ID: 05060116920512
• NIH Device Record Key: 6d9da981-4f77-48d9-8256-8abb65ae3b17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraSphere Y90 Glass Microspheres 13.5 GBq
• Version Model Number: 990700.SPE
• 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	05060116920512 [Primary]

FDA Product Code

• NAW: Microspheres Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

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• 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)