TheraSphere Y90 Glass Microspheres 8.5 GBq (US Clinical)

GUDID 05060116921830

TheraSphere Yttrium-90 Glass Microspheres 8.5 GBq Dose (US Clinical)

BIOCOMPATIBLES UK LTD

Manual brachytherapy source, permanent implant

• Primary Device ID: 05060116921830
• NIH Device Record Key: cd6c8992-154a-41ae-835c-034ac260717e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraSphere Y90 Glass Microspheres 8.5 GBq (US Clinical)
• Version Model Number: OTT-SPE-FP-700 (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@bsci.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060116920420 [Previous]
GS1	05060116921830 [Primary]

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: 2020-06-29
• Device Publish Date: 2020-06-19

Devices Manufactured by BIOCOMPATIBLES UK LTD

• 05060116921328 - Varithena® Administration Pack: 2020-10-08 The Varithena® administration pack (convenience kit) contents: (1 Varithena Transfer Unit, 3 Silicon-free Syringes, 1 Manometer
• 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)