Identity
- Trade Name
- NA FDA UDI
- Generic Name
- Radio-frequency ablation system FDA UDI
- Device Name
- Footswitch EUDAMEDFoot Switch FDA UDI
- Model / Reference
- FS-1 EUDAMEDFDA UDI
- Description
- Foot Switch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813250011746 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000080MQ EUDAMED
- FDA Product Code
- GXI FDA UDIGXD FDA UDI
- EMDN Code
- K020380 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - ACCESSORIES EUDAMED
- GMDN Term
- Radio-frequency ablation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4725 FDA UDI882.4400 FDA UDI
- Market of Registration
- Netherlands 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency ablation system
Footswitch by Boston Scientific Neuromodulation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Radio-frequency ablation system.
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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 | 01915060000000000000080MQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Neuromodulation Corporation
- EUDAMED SRN
- US-MF-000004703
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 1dd91017-7650-47c8-888f-19a44cc8240c 61 fields · synced Jun 18, 2026
- FDA UDI 6fe7c9bb-9edb-4aba-87f1-3122a3e32aeb 33 fields · synced May 30, 2026