Identity
- Trade Name
- ULITE PHACO HANDPIECE FDA UDI
- Generic Name
- Phacoemulsification system handpiece FDA UDI
- Device Name
- This active reusable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique. FDA UDI
- Model / Reference
- 303060-0001-000 FDA UDI
- Description
- This active reusable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049539100184 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Phacoemulsification system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Phacoemulsification system handpiece
Ulite Phaco Handpiece by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification system handpiece.
- 2.2 mm Reusable phaco set with 30° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- 2.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x reusab — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Millennium — Bausch & Lomb Incorporated · Class II
- MICS 1.8 mm Reusable phaco set with 30° angled flared needle Note: Maximum 20x r — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Irrigation sleeve for 2.5 mm phaco needle. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- 2.2 mm Reusable phaco set with 45° straight flared needle — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Phaco fragmentation needles, 23G / 0.6 mm, incl. needle wrench. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Irrigation sleeve for 1.8 mm phaco needle. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
Sources (1)
- FDA UDI 75b0649c-c6d6-467e-b0c4-c70895e76997 33 fields · synced May 30, 2026