Home GUDID 05060116921564 TheraSphere Y90 Glass Microspheres 12.5 GBq (US Commercial)
Primary DI 05060116921564
Brand TheraSphere Y90 Glass Microspheres 12.5 GBq (US Commercial)
Company BIOCOMPATIBLES UK LTD
Model OTT-SPE-FP-700 (990700.SPE)
Device description TheraSphere Yttrium-90 Glass Microspheres 12.5 GBq Dose (US Commercial)
Published 2020-06-19
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 05060116920499 Previous GS1 0 05060116921564 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060116920499 05060116920499 5060116920499 05060116921564 05060116921564 5060116921564
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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05060116920635 TheraSphere Administration Set OTT-SPE-FP-001 2018-11-01 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 05060116921397 TheraSphere Y90 Glass Microspheres 4.0 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 05060116921540 TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19 05060116921557 TheraSphere Y90 Glass Microspheres 12.0 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19
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