Home GUDID 04251867200102 Patient spoon with connecting cable TheraBionic P1 - Version 3
Primary DI 04251867200102
Brand Patient spoon with connecting cable TheraBionic P1 - Version 3
Company TheraBionic GmbH
Model 03
Catalog number THBC P1-S-03
Device description Patient spoon with connecting cable TheraBionic P1 - Version 3
Published 2024-04-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name QOM Stimulator, Electric Field, Intrabuccal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QOM Stimulator, Electric Field, Intrabuccal
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04251867200102 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04251867200102 04251867200102 4251867200102
GMDN Terms# Term, Definition table Term Definition Alternating electric field antimitotic cancer treatment system generator A portable, battery-powered component of an alternating electric field cancer treatment system designed to generate intermediate-frequency (100-300 kHz) alternating electric current to treat certain forms of recurrent or newly-diagnosed cancer; typically glioblastoma multiforme (GBM) [malignant brain tumour]. Also known as tumour treatment fields (TTFields) or (TTF), the treatment is usually intended to be used as a home-use supplement to primary therapies (e.g., surgery, radiotherapy, and/or chemotherapy). Designed to be carried by the patient it is powered by a rechargeable battery pack or via a mains power supply and is connected to a head-worn transducer array via a connection cable.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Temperature range of -20°C - +60°C, humidity range of 0% - 90%, pressure range of 700hPa - 1200 hPa
Regulatory Flags# DUNS number 312894281 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label false 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 04251867200126 TheraBionic P1 THBC P1-S-04 THBC P1-S-04 2025-06-04 04251867200089 Therabionic P1 05 THBC P1-TU-1.1 2024-04-24 04251867200119 Therabionic P1 02 THBC P1-PS-02 2024-04-24 04251867200096 Docking station TheraBionic P1 07 THBC P1-DS-1.1 2024-04-23 04251867200072 TheraBionic P1 THBC P1 1.1-US-HDE THBC P1 1.1-US-HDE 2024-02-09
Other Devices Sharing Product Codes# 
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