FDA.reportPublic FDA data

Avazzia

Primary DI
00851530007225
Brand
Avazzia
Company
AVAZZIA INC
Model
AA-US
Catalog number
AA-US
Device description
Uro Probe, Slim
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
KPIStimulator, Electrical, Non-Implantable, For Incontinence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPIStimulator, Electrical, Non-Implantable, For IncontinenceGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851530007225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851530007225008515300072258515300072250851530007225

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
00851530007232AvazziaAA-URAA-UR2016-09-23
00851530007256AvazziaA4-EN-KA4-EN-K2016-12-19
00851530007287AvazziaAA-CP-FaceAA-CP-Face2016-09-23
00851530007294AvazziaAA-CP-EyeAA-CP-Eye2016-09-23
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
06942808259034Intrelief PFEEasyMed Instruments Co., Ltd.KPI2026-05-05
04719872333104LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333593LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872333616LevinaZMI ELECTRONICS LTD.KPI2026-04-14
04719872334033LevinaZMI ELECTRONICS LTD.KPI2026-04-14
03830054238138QuantumStar, StarFormerFOTONA d.o.o.KPI2025-06-12
05033435134403TensCareTENSCARE LIMITEDKPI2024-11-18
G680LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceBLISSCO MEDICAL DEVICE LIMITEDKPI2024-11-14
LT2061Neocontrol Pelvic Floor Therapy System, Incontinence Treatment DeviceBLISSCO MEDICAL DEVICE LIMITEDKPI2024-11-14
03830054237728StarFormerFOTONA d.o.o.KPI2024-07-30
00092237626047Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
00092237626054Richmar EMG ProDrive Devilbiss HealthcareKPI2024-06-28
06970935830482KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830499KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830642KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830659KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830666KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830673KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830680KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
06970935830697KONMEDShenzhen Konmed Technology Co., Ltd.KPI2024-03-05
05033435135646TensCareTENSCARE LIMITEDKPI2023-10-24
04053815076711MFG-05Zimmer MedizinSysteme GmbHKPI2023-10-16
00860000860000Yarlap IRelevium Labs, Inc.KPI2023-10-07
00860000860031Yarlap IIRelevium Labs, Inc.KPI2023-10-07
05033435070039TensCareTENSCARE LIMITEDKPI2023-08-31
04719871189108iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-30
04719871184769LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184776LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184783LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25
04719871184790LifecareEVERYWAY MEDICAL INSTRUMENTS CO., LTD.KPI2023-08-25