Home GUDID 05060116921397 TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial)
Primary DI 05060116921397
Brand TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial)
Company BIOCOMPATIBLES UK LTD
Model OTT-SPE-FP-700 (990700.SPE)
Device description TheraSphere Yttrium-90 Glass Microspheres 4.0 GBq Dose (US Commercial)
Published 2020-06-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name NAW Microspheres Radionuclide
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NAW Microspheres Radionuclide Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060116920352 Previous GS1 0 05060116921397 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060116920352 05060116920352 5060116920352 05060116921397 05060116921397 5060116921397
GMDN Terms# Term, Definition table Term Definition Manual brachytherapy source, permanent implant A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.
Regulatory Flags# DUNS number 222870839 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060116921168 LC Bead LUMI 100 - 300 RO2L103 2016-08-11 05060116921205 LC Bead LUMI 300 - 500 RO2L305 2016-08-11 05060116920635 TheraSphere Administration Set OTT-SPE-FP-001 2018-11-01 05060116921328 Varithena® Administration Pack FP00024 2020-09-30 05060116921373 TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921380 TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921403 TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921410 TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921427 TheraSphere Y90 Glass Microspheres 5.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921434 TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921441 TheraSphere Y90 Glass Microspheres 6.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921458 TheraSphere Y90 Glass Microspheres 7.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921465 TheraSphere Y90 Glass Microspheres 7.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921472 TheraSphere Y90 Glass Microspheres 8.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921489 TheraSphere Y90 Glass Microspheres 8.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921496 TheraSphere Y90 Glass Microspheres 9.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921502 TheraSphere Y90 Glass Microspheres 9.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921519 TheraSphere Y90 Glass Microspheres 10.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921526 TheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921533 TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19
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