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 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 05060116920642 Package GS1 5 Not in Commercial Distribution 05060116920659 Package GS1 20 Not 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 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 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 05060116921564 TheraSphere Y90 Glass Microspheres 12.5 GBq (US Commercial) OTT-SPE-FP-700 (990700.SPE) 2020-06-19
Other Devices Sharing Product Codes# 
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