Identity
- Trade Name
- THERMOCOOL SF BI-DIRECTIONAL CATHETER EUDAMEDThermoCool SF FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Model / Reference
- BDI35BFRT EUDAMEDFDA UDI
Identifiers
- Catalog Number
- BDI35BFRT FDA UDI
- Primary DI / UDI-DI
- D-USMF000014219000032QH EUDAMED10846835002799 FDA UDI
- Basic UDI-DI
- B-USMF000014219000032QH EUDAMED
- FDA Product Code
- OAD FDA UDI
- EMDN Code
- C020301 ARRHYTHMOGENIC FOCI RADIOFREQUENCY ABLATION CATHETERS EUDAMED
- GMDN Term
- Cardiac radio-frequency ablation system catheter FDA UDI
Classification
- Device Class
- Class III EUDAMEDFDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiac radio-frequency ablation system catheter
ThermoCool SF by Biosense Webster Inc — Class III — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac radio-frequency ablation system catheter.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
Sources (2)
- FDA UDI 877b3a14-5be7-48e0-8e7d-94820037f2b6 35 fields · synced Jun 20, 2026
- EUDAMED 3023a1a1-6734-4958-90e3-b1028a008077 61 fields · synced Jun 20, 2026