Identity
- Trade Name
- Sonata® Procedure Kit FDA UDI
- Generic Name
- Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, two model DE-001 single-use electrosurgical return electrodes, and one model ACCY-007 sterile single-use electrosurgical handpiece cable. FDA UDI
- Model / Reference
- PROKIT-001 FDA UDI
- Description
- Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, two model DE-001 single-use electrosurgical return electrodes, and one model ACCY-007 sterile single-use electrosurgical handpiece cable. FDA UDI
Identifiers
- Catalog Number
- PROKIT-001 FDA UDI
- Primary DI / UDI-DI
- 10817929020166 FDA UDI
- 510(k) Number
- K193516 FDA UDI
- FDA Product Code
- KNF FDA UDI
- GMDN Term
- Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4160 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Sonata® Procedure Kit by Gynesonics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Gynesonics, Inc.
Sources (1)
- FDA UDI a6e12304-3933-417a-9045-626cf29d9819 38 fields · synced May 30, 2026