Identity
- Trade Name
- 305mm Single Action Grasper EUDAMEDLogic - Laparoscopic Instrument System FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- 305mm Single Action Grasper EUDAMEDFDA UDI
- Model / Reference
- 101-48034 EUDAMEDFDA UDI
- Description
- 305mm Single Action Grasper FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986008141 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051986008141 EUDAMED
- 510(k) Number
- K111986 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER 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
Category: Electrical-only medical device connection cable, reusable
305mm Single Action Grasper by Surgical Innovations Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-05051986008141 | 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 8d967ced-f9a2-46bc-995f-afecb03fc286 61 fields · synced Jul 29, 2026
- FDA UDI 48d7a8e0-6a66-4a66-99de-8d769c23a5af 34 fields · synced May 30, 2026