Dry Flex-T

Primary DI
B675DRYFLEXT1
Brand
Dry Flex-T
Company
ZETO, INC.
Model
ZP-200-43211
Catalog number
ZP-200-43211
Device description
Dry Flex Electrodes - Bristle Tall
Published
2021-01-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172735000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172735000WR19 SystemZeto, Inc.2018-04-17GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B675DRYFLEXT1PrimaryHIBCC0
B675DRYFLEXT2Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA 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
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place, away from direct sunlight

Contacts#

Phone, Email table
PhoneEmail
8339386334info@zetoinc.com

Regulatory Flags#

DUNS number
079582566
Device count
10
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 DIBrandModelCatalogPublished
B675DRYFLATS1Dry Flat-SZP-210-41211ZP-210-412112021-01-25
B675DRYFLEXM1Dry Flex-MZP-200-42211ZP-200-422112021-01-25
B675PDDU0Zeto ONE Display UnitZP-140-110112025-11-19
B675SOFTFLATT1Soft Flat-TZP-210-52011ZP-210-520112021-01-25
B675ONEHUL0Zeto ONE Head Unit - RegularZP-120-110312026-03-13
B675ONEHUS0Zeto ONE Head Unit - SmallZP-120-110212026-03-13
B675ONEHUL1Zeto ONE Head Unit - RegularZP-120-110312025-07-09
B675ONEHUS1Zeto ONE Head Unit - SmallZP-120-110212025-07-09
B675ONELTES1Zeto ONE Long-Term Electrode SetZP-200-670312025-07-09
B675ONESTES1Zeto ONE Short-Term Electrode SetZP-200-670812025-07-09
B675DC0Zeto ONE Disinfection Container with LidZP-301-100012024-11-20
B675MM0Zeto All-in-One Medical Grade PCZP-340-700012024-11-20
B675ONEAUX1Zeto ONE AUX Cable Extension SetZP-230-300212024-06-11
B675ONEDU0Zeto ONE Display UnitZP-140-110012024-06-11
B675ONEECG1Zeto ONE ECG Cable Extension SetZP-230-300112024-06-11
B675ONEEMG1Zeto ONE EMG Cable Extension SetZP-230-300512024-06-11
B675ONEESB1Zeto ONE Electrode Set — BasicZP-200-670012024-06-11
B675ONEHEOG1Zeto ONE HEOG Cable Extension SetZP-230-300312024-06-11
B675ONEHU1Zeto ONE Head UnitZP-120-110112024-06-11
B675ONEREF1Zeto ONE REF Cable ExtensionZP-230-300612024-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02