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Horizontal Handle without Ratchet
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 101-41000
Identity
- Trade Name
- Horizontal Handle without Ratchet EUDAMEDLogic - Laparoscopic Instrument System FDA UDI
- Generic Name
- Electrocautery system handpiece FDA UDI
- Device Name
- Logic Handle EUDAMEDHorizontal Handle without Ratchet EUDAMEDFDA UDI
- Model / Reference
- 101-41000 EUDAMEDFDA UDI
- Description
- Horizontal Handle without Ratchet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986000039 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051986SIRUH4E EUDAMEDB-05051986000039 EUDAMED
- Direct Marketing DI
- 05051986000039 EUDAMED
- 510(k) Number
- K063485 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- L180302 ENDOSCOPIC ELECTROSURGERY HANDPIECES, REUSABLE EUDAMED
- GMDN Term
- Electrocautery system handpiece FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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
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
Moist Heat or Steam Sterilization FDA UDI
Horizontal Handle without Ratchet by Surgical Innovations Ltd. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 5051986SIRUH4E | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5051986SIRUH4E | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (3)
- EUDAMED f0635604-99aa-42ec-a5f3-49043fcf2682 61 fields · synced Jul 28, 2026
- EUDAMED 2f1f2726-974f-42f6-aea1-9d4c7045a1aa 61 fields · synced May 19, 2026
- FDA UDI 647f9f93-3b19-46c7-b04d-0a9ecca09559 34 fields · synced May 30, 2026