Identity
- Trade Name
- Simplicity™ EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use FDA UDI
- Device Name
- IonicRF Generator, Grounding pad and Simplicity III Disposable Radiofrequency Electrodes EUDAMEDDisposable Radiofrequency Electrode FDA UDI
- Model / Reference
- RFDE-SI EUDAMEDIII FDA UDI
- Description
- Disposable Radiofrequency Electrode FDA UDI
Identifiers
- Catalog Number
- RFDE-SIRFDE-SI FDA UDI
- Primary DI / UDI-DI
- 05415067028976 EUDAMEDFDA UDI
- Basic UDI-DI
- 5415067RFA0002EN EUDAMED
- FDA Product Code
- GXI FDA UDI
- EMDN Code
- K02030101 RADIOFREQUENCY SURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4725 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
Yes
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use
Simplicity™ by St. Jude Medical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation probe, denervation, monopolar, single-use.
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- Halyard — Avanos Medical, Inc. · Class II
- Epimed — MINTA MEDICAL LIMITED · Class II
- Epimed — MINTA MEDICAL LIMITED · Class II
- Nimbus Probe (Disposable) — Stratus Medical LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- St. Jude Medical, Inc.
Sources (2)
- FDA UDI f7c99d00-f6ca-4da3-9420-38ec8159be61 36 fields · synced Jun 19, 2026
- EUDAMED 536d02d1-3ae1-4da2-8dac-d9729e93e406 61 fields · synced Jun 19, 2026