TheraSphere iDOC

GUDID 05060116921212

The TheraSphere iDOC is an interactive Dose Ordering Calculator that will assist in calculating and ordering the appropriate TheraSphere dose vial siz

BIOCOMPATIBLES UK LTD

Calculator, programmable

• Primary Device ID: 05060116921212
• NIH Device Record Key: ee38ca82-ca2d-4d0d-836c-aeb65386d479
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraSphere iDOC
• Version Model Number: OTT-SPE-FP-002
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060116921212 [Primary]

FDA Product Code

• NAW: Microspheres Radionuclide

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-04
• Device Publish Date: 2019-01-02

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)