FDA.reportPublic FDA data

Avazzia

Primary DI
00851530007294
Brand
Avazzia
Company
AVAZZIA INC
Model
AA-CP-Eye
Catalog number
AA-CP-Eye
Device description
Conductive Eye Mask
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851530007294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851530007294008515300072948515300072940851530007294

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
603638607
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851530007829AvazziaAA-LW-4P-250F-60KAA-LW-4P-250F-60K2026-04-24
00851530007621AvazziaA4-EBA4-EB2026-04-21
00851530007638AvazziaA4-EB-KA4-EB-K2026-04-21
00851530007881AvazziaA4-TB2A4-TB22026-04-21
00851530007898AvazziaA4-PLA4-PL2026-04-21
00851530007904AvazziaA4-PL-KA4-PL-K2026-04-21
00851530007645AvazziaA4-TB OTCA4-TB-OTC2026-03-31
00851530007744AvazziaA4-AG OTCA4-AG OTC2020-07-15
00851530007751AvazziaA4-AG-K-Y OTCA4-AG-K-Y OTC2020-07-15
00851530007768AvazziaA4-AG-K OTCA4-AG-K OTC2020-07-15
00851530007034AvazziaA4-ALA4-AL2016-09-23
00851530007102AvazziaA4-TBA4-TB2016-09-23
00851530007225AvazziaAA-USAA-US2016-09-23
00851530007232AvazziaAA-URAA-UR2016-09-23
00851530007256AvazziaA4-EN-KA4-EN-K2016-12-19
00851530007287AvazziaAA-CP-FaceAA-CP-Face2016-09-23
00851530007300AvazziaAA-CG-GloveAA-CG-Glove2016-09-23
00851530007317AvazziaAA-CG-SockAA-CG-Sock2016-09-23
00851530007324AvazziaAA-CG-ArmAA-CG-Arm2016-09-23
00851530007331AvazziaAA-CG-LegAA-CG-Leg2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
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