Home GUDID B675SOFTFLEXT1 Soft Flex-T
Primary DI B675SOFTFLEXT1
Brand Soft Flex-T
Company ZETO, INC.
Model ZP-200-53011
Catalog number ZP-200-53011
Device description Soft Flex Electrodes - Tall
Published 2019-10-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name GXY Electrode, Cutaneous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXY Electrode, Cutaneous Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B675SOFTFLEXT1 Primary HIBCC 0 B675SOFTFLEXT0 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Analytical scalp electrode, single-use A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store in a cool, dry place, away from direct sunlight
Regulatory Flags# DUNS number 079582566 Device count 25 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B675DRYFLATS1 Dry Flat-S ZP-210-41211 ZP-210-41211 2021-01-25 B675DRYFLEXM1 Dry Flex-M ZP-200-42211 ZP-200-42211 2021-01-25 B675DRYFLEXT1 Dry Flex-T ZP-200-43211 ZP-200-43211 2021-01-25 B675PDDU0 Zeto ONE Display Unit ZP-140-11011 2025-11-19 B675SOFTFLATT1 Soft Flat-T ZP-210-52011 ZP-210-52011 2021-01-25 B675ONEHUL0 Zeto ONE Head Unit - Regular ZP-120-11031 2026-03-13 B675ONEHUS0 Zeto ONE Head Unit - Small ZP-120-11021 2026-03-13 B675ONEHUL1 Zeto ONE Head Unit - Regular ZP-120-11031 2025-07-09 B675ONEHUS1 Zeto ONE Head Unit - Small ZP-120-11021 2025-07-09 B675ONELTES1 Zeto ONE Long-Term Electrode Set ZP-200-67031 2025-07-09 B675ONESTES1 Zeto ONE Short-Term Electrode Set ZP-200-67081 2025-07-09 B675DC0 Zeto ONE Disinfection Container with Lid ZP-301-10001 2024-11-20 B675MM0 Zeto All-in-One Medical Grade PC ZP-340-70001 2024-11-20 B675ONEAUX1 Zeto ONE AUX Cable Extension Set ZP-230-30021 2024-06-11 B675ONEDU0 Zeto ONE Display Unit ZP-140-11001 2024-06-11 B675ONEECG1 Zeto ONE ECG Cable Extension Set ZP-230-30011 2024-06-11 B675ONEEMG1 Zeto ONE EMG Cable Extension Set ZP-230-30051 2024-06-11 B675ONEESB1 Zeto ONE Electrode Set — Basic ZP-200-67001 2024-06-11 B675ONEHEOG1 Zeto ONE HEOG Cable Extension Set ZP-230-30031 2024-06-11 B675ONEHU1 Zeto ONE Head Unit ZP-120-11011 2024-06-11
Other Devices Sharing Product Codes# 
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