Identity
- Trade Name
- 5-12 Single Use Universal Seal EUDAMEDYelloPort Elite - Laparoscopic Port Access System FDA UDI
- Generic Name
- Laparoscopic access cannula seal, single-use FDA UDI
- Device Name
- Single use Seal / Valve EUDAMED5-12 Single Use Universal Seal EUDAMEDFDA UDI
- Model / Reference
- EA512US EUDAMEDFDA UDI
- Description
- 5-12 Single Use Universal Seal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051986001562 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051986SISUS59 EUDAMEDB-05051986001562 EUDAMED
- 510(k) Number
- K190592 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- K01020110 MINIMALLY INVASIVE SURGERY CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic access cannula seal, single-use 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
5-12 Single Use Universal Seal 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 | 5051986SISUS59 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5051986SISUS59 | 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 7794d154-393a-40a2-a19e-a8e64429eba9 61 fields · synced Jul 13, 2026
- EUDAMED bc4a0c31-ab66-4073-a4d8-3a90449f7730 61 fields · synced May 19, 2026
- FDA UDI 0f2b6fc1-9c4c-4d8b-ab88-4225ced56068 34 fields · synced May 30, 2026