Identity
- Trade Name
- 305mm Dolphin nose Without Cup EUDAMEDLogic - Laparoscopic Instrument System FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- 305mm Dolphin nose Without Cup EUDAMEDFDA UDI
- Model / Reference
- 101-48046 EUDAMEDFDA UDI
- Description
- 305mm Dolphin nose Without Cup FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986009889 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051986009889 EUDAMED
- 510(k) Number
- K111986 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180802 ENDOSCOPIC ELECTROSURGERY MANIPULATORS, REUSABLE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Moist Heat or Steam Sterilization FDA UDI
305mm Dolphin nose Without Cup by Surgical Innovations Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05051986009889 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Surgical Innovations Ltd.
- EUDAMED SRN
- GB-MF-000012187
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED 87ec7346-0168-45c9-9e57-09562dc88ff3 61 fields · synced Jun 18, 2026
- FDA UDI 7d1d38fa-2acc-4ba3-8bf2-eb899850bb0e 34 fields · synced May 27, 2026