Identity
- Trade Name
- Sonata RFA Cable, reusable EUDAMEDSonata® RFA Handpiece Cable, Reusable FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Sonata RFA Cable, reusable EUDAMEDElectrical-only medical device connection cable, reusable FDA UDI
- Model / Reference
- ACCY-008 EUDAMEDFDA UDI
- Description
- Electrical-only medical device connection cable, reusable FDA UDI
Identifiers
- Catalog Number
- ACCY-008 FDA UDI
- Primary DI / UDI-DI
- 30817929020177 EUDAMEDFDA UDI
- Basic UDI-DI
- 081792902RFACBLC9 EUDAMED
- Direct Marketing DI
- 30817929020177 EUDAMED
- 510(k) Number
- K211535 FDA UDI
- FDA Product Code
- KNF FDA UDI
- EMDN Code
- Z12080280 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4160 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Sonata RFA Cable, reusable by Gynesonics, Inc. — 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 | 081792902RFACBLC9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Gynesonics, Inc.
- EUDAMED SRN
- US-MF-000017044
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED cd8fa8aa-eba8-4f36-9558-046f778fe404 61 fields · synced Jun 18, 2026
- FDA UDI 4d9f1733-3471-4629-b2b3-5ca734b8b431 37 fields · synced May 29, 2026