Identity
- Trade Name
- 5x55 Locking Shielded Trocar EUDAMEDYelloPort Elite - Laparoscopic Port Access System FDA UDI
- Generic Name
- Laparoscopic trocar blade, reusable FDA UDI
- Device Name
- Reusable Trocar EUDAMED5x55 Locking Shielded Trocar FDA UDI
- Model / Reference
- ET0505509 EUDAMEDFDA UDI
- Description
- 5x55 Locking Shielded Trocar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986013503 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051986SIRUT56 EUDAMED
- 510(k) Number
- K210495 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L031299 SURGICAL TROCAR, REUSABLE - OTHER EUDAMED
- GMDN Term
- Laparoscopic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Northern 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
5x55 Locking Shielded Trocar by Surgical Innovations Ltd. — Class IIa — 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 | 5051986SIRUT56 | 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 (2)
- EUDAMED 14e469ff-f4a5-4945-b209-7e5800236aa4 61 fields · synced Jul 13, 2026
- FDA UDI c2f22613-b562-458c-a682-8f5c3ad750d3 34 fields · synced May 24, 2026