Identity
- Trade Name
- NOGASTAR CARDIOLOGY CATHETER EUDAMEDNoga-Star FDA UDI
- Generic Name
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
- Model / Reference
- 120708S EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 120708S FDA UDI
- Primary DI / UDI-DI
- D-USMF000014219000023QG EUDAMED10846835002058 FDA UDI
- Basic UDI-DI
- B-USMF000014219000023QG EUDAMED
- 510(k) Number
- K954390 FDA UDI
- FDA Product Code
- DRF FDA UDI
- EMDN Code
- C020105 NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS EUDAMED
- GMDN Term
- Cardiac mapping catheter, percutaneous, single-use FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1220 FDA UDI
- Commercial Distribution
- Not 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
Noga-Star by Biosense Webster Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
Sources (2)
- FDA UDI 65399894-1dfd-48ed-9d8d-af968b4f425c 37 fields · synced Jun 19, 2026
- EUDAMED 8b7b09d7-8b01-4f13-83e6-191c79bbb36c 61 fields · synced Jun 19, 2026