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Diagnostic Catheter Sterile Cable
EUDAMEDFDA UDIClass I (EU MDR)
Ref M0045454S0
Identity
- Trade Name
- Polaris X™ FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Diagnostic Catheter Sterile Cable EUDAMEDCatheter Cable, Sterile Cable FDA UDI
- Model / Reference
- M0045454S0 EUDAMEDFDA UDI
- Description
- Catheter Cable, Sterile Cable FDA UDI
Identifiers
- Catalog Number
- M0045454S0 FDA UDI
- Primary DI / UDI-DI
- 08714729269779 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000336N4 EUDAMED
- FDA Product Code
- DRF FDA UDI
- EMDN Code
- C020180 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1220 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Diagnostic Catheter Sterile Cable by Boston Scientific Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 01915060000000000000336N4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (2)
- EUDAMED 30ad55f0-5cb4-4b40-90ed-3c3bb2761433 61 fields · synced Aug 4, 2026
- FDA UDI 9247fe72-a4af-4b1d-917c-075cb5b0e9fd 34 fields · synced May 30, 2026