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Sonata IUUS Probe Connector Protector
EUDAMEDFDA UDIClass I (EU MDR)
Ref ACCY-018
Identity
- Trade Name
- Sonata IUUS Probe Connector Protector EUDAMEDSonata® IUUS Probe Connector Protector FDA UDI
- Generic Name
- Non-submersible device disinfection chamber FDA UDI
- Device Name
- Sonata IUUS Probe Connector Protector EUDAMEDAccessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Provides water-tight cover for the electrical connector of the IUUS Probe during liquid reprocessing procedures. FDA UDI
- Model / Reference
- ACCY-018 EUDAMEDFDA UDI
- Description
- Accessory to the Sonata® Intrauterine Ultrasound (IUUS) Probe. Provides water-tight cover for the electrical connector of the IUUS Probe during liquid reprocessing procedures. FDA UDI
Identifiers
- Catalog Number
- ACCY-018 FDA UDI
- Primary DI / UDI-DI
- 10817929020463 EUDAMEDFDA UDI
- Basic UDI-DI
- 081792902IUSPCCK9 EUDAMED
- Direct Marketing DI
- 10817929020463 EUDAMED
- 510(k) Number
- K222304 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z12080280 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Non-submersible device disinfection chamber FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 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
No
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
Sonata IUUS Probe Connector Protector 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 | 081792902IUSPCCK9 | 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 aba4391c-2321-44d2-a9c2-29850bf9442b 61 fields · synced Jun 18, 2026
- FDA UDI 342f3116-9c15-4d2d-9505-8a4f58be7bb3 37 fields · synced May 30, 2026