Identity
- Trade Name
- UltravisionTM FDA UDI
- Generic Name
- Surgical fluid/smoke waste management system FDA UDI
- Device Name
- Ultravision™ 5mm Trocar EUDAMEDUltravision Visual Field Clearing System FDA UDI
- Model / Reference
- DAD-003-013 EUDAMEDUltravision TM 5mm Trocar FDA UDI
- Description
- Ultravision Visual Field Clearing System FDA UDI
Identifiers
- Catalog Number
- DAD-003-013 FDA UDI
- Primary DI / UDI-DI
- 05060417680214 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060417680506041768021477 EUDAMED
- FDA Product Code
- PQM FDA UDI
- EMDN Code
- K02010107 SMOKE EVACUATION SYSTEMS EUDAMED
- GMDN Term
- Surgical fluid/smoke waste management system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5050 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Category: Surgical fluid/smoke waste management system
UltravisionTM by Alesi Surgical, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alesi Surgical, Ltd.
Sources (2)
- FDA UDI 2be33a58-11b3-49a1-b803-589cca4390fc 35 fields · synced Jun 19, 2026
- EUDAMED 68c4a026-0685-4715-87aa-2acd75817c1d 61 fields · synced Jun 19, 2026