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Adaptor Cable Bipolar For Use With Habib EndoHPB
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 5700
Identity
- Trade Name
- Adaptor Cable Bipolar FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Adaptor Cable Bipolar For Use With Habib EndoHPB EUDAMEDAdaptor Cable Bipolar, 22mm spacing FDA UDI
- Model / Reference
- 5700 EUDAMEDFDA UDI
- Description
- Adaptor Cable Bipolar, 22mm spacing FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729982562 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000048MU EUDAMED
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- K02010203 ELECTROSURGERY CONNECTION CABLES, SINGLE-USE EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Adaptor Cable Bipolar For Use With Habib EndoHPB by Boston Scientific Corporation — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231533 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 01915060000000000000048MU | Class I | Active |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-MF-000004702
- Authorised Representative
- Boston Scientific Limited IE-AR-000003840
Sources (3)
- EUDAMED be53304d-991a-4180-931c-36488027b9b8 61 fields · synced Jul 10, 2026
- FDA UDI 2840f62e-2db6-4ffb-95dd-6446432bdf79 34 fields · synced May 30, 2026
- FDA 510(k) K231533 1 fields · synced May 18, 2026