Identity
- Trade Name
- 10x75 Pencil Point Trocar EUDAMEDYelloPort Elite - Laparoscopic Port Access System FDA UDI
- Generic Name
- Laparoscopic trocar blade, reusable FDA UDI
- Device Name
- 10x75 Pencil Point Trocar EUDAMEDFDA UDI
- Model / Reference
- ET1007503 EUDAMEDFDA UDI
- Description
- 10x75 Pencil Point Trocar FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986012384 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05051986012384 EUDAMED
- 510(k) Number
- K190592 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
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
10x75 Pencil Point Trocar by Surgical Innovations Ltd. — Class IIa — 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-05051986012384 | 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 f6c81aaf-9495-492e-a33b-0ba43ff95612 61 fields · synced Jun 19, 2026
- FDA UDI 2dcef092-a114-4582-a31d-10daad335455 34 fields · synced May 30, 2026