Home GUDID 05060116920635 TheraSphere Administration Set
Primary DI 05060116920635
Brand TheraSphere Administration Set
Company BIOCOMPATIBLES UK LTD
Model OTT-SPE-FP-001
Device description Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres
Published 2018-11-01
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 05060116920642 Package GS1 5 In Commercial Distribution 05060116920659 Package GS1 20 In Commercial Distribution 05060116920635 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060116920642 05060116920642 5060116920642 05060116920659 05060116920659 5060116920659 05060116920635 05060116920635 5060116920635
GMDN Terms# Term, Definition table Term Definition Manual-afterloading brachytherapy system source delivery procedure kit A collection of sterile devices intended to dispense/collect hydraulic fluid used to deliver the radiation source train of a manual-afterloading brachytherapy system source transfer device to/from the delivery catheter/applicator. It consists of disposable devices such as syringes, fluid collection bags, adaptors/connectors. This is a single-use device.
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 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 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
Other Devices Sharing Product Codes# 
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