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
- UltravisionTM System Starter Pack FDA UDI
- Description
- UltravisionTM Visual Field Clearing System FDA UDI
Identifiers
- Catalog Number
- DAD-001-015 FDA UDI
- Primary DI / UDI-DI
- 05060417680009 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
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 8eae3954-aa2e-4687-92a0-019b8a21351e 36 fields · synced May 30, 2026