Identity
- Trade Name
- 5x55 Pencil Point Trocar EUDAMEDYelloPort Elite FDA UDI
- Generic Name
- Laparoscopic trocar blade, reusable FDA UDI
- Device Name
- 5x55 Pencil Point Trocar EUDAMEDFDA UDIReusable Trocar EUDAMED
- Model / Reference
- ET0505503 EUDAMEDFDA UDI
- Description
- 5x55 Pencil Point Trocar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986013176 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051986013176 EUDAMED5051986SIRUT56 EUDAMED
- Direct Marketing DI
- 05051986013176 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
- 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
No
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 Pencil Point Trocar by Surgical Innovations Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05051986013176 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05051986013176 | 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 9c188249-9670-44b5-a307-5e6cb6d2309a 61 fields · synced Jul 30, 2026
- EUDAMED 30a50566-3607-4a9d-9c95-a29dd858d3ba 61 fields · synced May 17, 2026
- FDA UDI 470d3ce7-070c-4a4d-9866-1d8cf2703d01 34 fields · synced May 30, 2026