Identity
- Trade Name
- Celsius FDA UDI
- Generic Name
- Cardiac radio-frequency ablation system catheter FDA UDI
- Model / Reference
- D7BTCDL252RT FDA UDI
Identifiers
- Catalog Number
- D7BTCDL252RT FDA UDI
- Primary DI / UDI-DI
- 10846835005219 FDA UDI
- PMA Number
- P950005 FDA UDI
- FDA Product Code
- DRF FDA UDI
- GMDN Term
- Cardiac radio-frequency ablation system catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1220 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
Celsius by Biosense Webster Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac radio-frequency ablation system catheter.
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Cleared under the same submission
P950005 also covers:
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — Biosense Webster Inc
- Celsius — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biosense Webster Inc
Sources (1)
- FDA UDI 16377b9f-98b3-4958-9fb4-9fd4c6e68141 36 fields · synced Jun 8, 2026