Identity
- Trade Name
- ThermoCool SmartTouch FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Model / Reference
- D132701 FDA UDI
Identifiers
- Catalog Number
- D132701 FDA UDI
- Primary DI / UDI-DI
- 10846835009163 FDA UDI
- FDA Product Code
- LPB FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system catheter FDA UDI
Classification
- Device Class
- Class III 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: Cardiac radio-frequency ablation system catheter
ThermoCool SmartTouch by Biosense Webster Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
P030031 also covers:
- Celsius RMT ThermoCool — Biosense Webster Inc
- Celsius ThermoCool — Biosense Webster Inc
- Celsius ThermoCool — Biosense Webster Inc
- Celsius ThermoCool — Biosense Webster Inc
- Celsius ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool — Biosense Webster Inc
- EZ Steer ThermoCool NAV — Biosense Webster Inc
- EZ Steer ThermoCool NAV — Biosense Webster Inc
P040036 also covers:
- ThermoCool SmartTouch — Biosense Webster Inc
- ThermoCool SmartTouch — Biosense Webster Inc
- ThermoCool SmartTouch — Biosense Webster Inc
- ThermoCool SmartTouch — Biosense Webster Inc
- ThermoCool SmartTouch — Biosense Webster Inc
- ThermoCool SmartTouch — Biosense Webster Inc
- ThermoCool SmartTouch — Biosense Webster Inc
- nGEN Generator D138402 — Biosense Webster 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 III | Pending data |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
Sources (1)
- FDA UDI d2ffe905-c2ea-48f7-81f0-474bcf68404a 36 fields · synced Jun 1, 2026