Identity
- Trade Name
- SideKick™ 2 FDA UDI
- Generic Name
- Radio-frequency ablation system FDA UDI
- Device Name
- Siliconized 15cm x 10mm x 18ga (1.2mm) FDA UDI
- Model / Reference
- RFK-C151018S-ZK2 FDA UDI
- Description
- Siliconized 15cm x 10mm x 18ga (1.2mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00191506013110 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Radio-frequency ablation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4725 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: Radio-frequency ablation system
SideKick™ 2 by Boston Scientific Neuromodulation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency ablation system.
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
- Cavi di connessione — ADVANCED MEDICAL SYSTEMS GROUP S.R.L. · Class I
- RF Ablation Electrode Kits — SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · Class IIb
- CP-16 TIP — Jeisys Medical Inc. · Class IIb
- 10THERMA Electrode — TENTECH Inc. · Class IIb
- Acessa ProVu PFG Table Clamp — ACESSA HEALTH INC. · Class II
- DIAMOND TIP — Jeisys Medical Inc. · Class IIb
- Dophi — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Scientific Neuromodulation
Sources (1)
- FDA UDI 6f6683d2-677f-41a1-be4b-9af2f8293fce 34 fields · synced Jun 8, 2026