Identity
- Trade Name
- UltravisionTM FDA UDI
- Generic Name
- Surgical fluid/smoke waste management system FDA UDI
- Device Name
- UltravisionTM Visual Field Clearing System FDA UDI
- Model / Reference
- Patient Return Adaptor 1.5M (solid) FDA UDI
- Description
- UltravisionTM Visual Field Clearing System FDA UDI
Identifiers
- Catalog Number
- DAD-001-029 FDA UDI
- Primary DI / UDI-DI
- 05060417680078 FDA UDI
- 510(k) Number
- DEN150022 FDA UDI
- FDA Product Code
- PQM FDA UDI
- GMDN Term
- Surgical fluid/smoke waste management system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 1.5 Meter FDA UDI
Category: Surgical fluid/smoke waste management system
UltravisionTM by Alesi Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
DEN150022 also covers:
- UltravisionTM — Alesi Surgical, Ltd.
- UltravisionTM — Alesi Surgical, Ltd.
- UltravisionTM — Alesi Surgical, Ltd.
- UltravisionTM — Alesi Surgical, Ltd.
- UltravisionTM — Alesi Surgical, Ltd.
- UltravisionTM — Alesi Surgical, Ltd.
- UltravisionTM — Alesi Surgical, Ltd.
- UltravisionTM — Alesi Surgical, Ltd.
- UltravsionTM — Alesi Surgical, Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alesi Surgical, Ltd.
Sources (1)
- FDA UDI 0502bce9-c1a3-4396-b219-bc527e0febc6 37 fields · synced Jun 8, 2026