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Pg470/500/Us
EUDAMEDFDA UDIClass I (EU MDR)
Ref PG470/500/USModel Fully gelled electrodes for neurostimulation
by FIAB S.p.A.
Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
- Device Name
- Disposable fully gelled ready to use electrodes, 35x45mm doimensions. PG470/500/US model is especially indicated in electrotherapy. High material flexibility permits to apply electrodes very easily on treating areas. Solid gel maintains unchanged the electrode adhesion and conductivity, during procedure. The products are Latex free FDA UDI
- Model / Reference
- Fully gelled electrodes for neurostimulation EUDAMEDPG470/500/US EUDAMEDFDA UDI
- Description
- Disposable fully gelled ready to use electrodes, 35x45mm doimensions. PG470/500/US model is especially indicated in electrotherapy. High material flexibility permits to apply electrodes very easily on treating areas. Solid gel maintains unchanged the electrode adhesion and conductivity, during procedure. The products are Latex free FDA UDI
Identifiers
- Catalog Number
- PG470/500/US FDA UDI
- Primary DI / UDI-DI
- 08054242449297 EUDAMEDFDA UDI
- Basic UDI-DI
- 803300326208000001PF EUDAMED
- 510(k) Number
- K091163 FDA UDI
- FDA Product Code
- GXY FDA UDI
- EMDN Code
- N010299 NEUROLOGIC PHYSIOTHERAPHY DEVICES - OTHER EUDAMED
- GMDN Term
- Transcutaneous electrical stimulation electrode, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Pg470/500/Us by FIAB S.p.A. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803300326208000001PF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (2)
- EUDAMED 2d64aa2a-2200-42ff-aa16-aca640ea88ce 61 fields · synced Jun 19, 2026
- FDA UDI c103422f-166b-4e36-8d58-c4edb559e969 37 fields · synced May 30, 2026