Identity
- Trade Name
- DYONICS RF FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- DYONICS RF CONTRACT 30 DEG FDA UDI
- Model / Reference
- 72202147 FDA UDI
- Description
- DYONICS RF CONTRACT 30 DEG FDA UDI
Identifiers
- Catalog Number
- 72202147 FDA UDI
- Primary DI / UDI-DI
- 03596010625144 FDA UDI
- 510(k) Number
- K093165 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Dyonics Rf by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
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Cleared under the same submission
K093165 also covers:
- DYONICS RF — Smith & Nephew, Inc.
- DYONICS RF, ABLATION — Smith & Nephew, Inc.
- DYONICS RF, BROADNOSE — Smith & Nephew, Inc.
- DYONICS RF, CROSS — Smith & Nephew, Inc.
- DYONICS RF, CURVE — Smith & Nephew, Inc.
- DYONICS RF, DYNAMO — Smith & Nephew, Inc.
- DYONICS RF, HEDGEHOG — Smith & Nephew, Inc.
- DYONICS RF, HOOK — Smith & Nephew, Inc.
- DYONICS RF, ROUND — Smith & Nephew, Inc.
- DYONICS RF, SLICE — Smith & Nephew, Inc.
- DYONICS RF, WHIRLWIND — Smith & Nephew, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 59308d06-1a12-4762-aea7-704e4bfe0aee 36 fields · synced Jun 8, 2026