Alcon, Kelman, TurboSonics, Mini-Flared ABS
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- TurboSonics , ABS , Kelman EUDAMEDAlcon, Kelman, TurboSonics, Mini-Flared ABS FDA UDIAlcon, Kelman, TurboSonics, ABS FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, single-use FDA UDI
- Device Name
- TurboSonics U/S Tips EUDAMED45° Kelman®, 0.9 mm TurboSonics® Mini-Flared ABS® Tip FDA UDI45° Kelman®, 0.9 mm TurboSonics® ABS® Mini Tip FDA UDI30° Kelman®, 0.9 mm TurboSonics® Mini-Flared ABS® Tip FDA UDI
- Model / Reference
- 8065750853 EUDAMEDFDA UDI8065750852 EUDAMEDFDA UDI8065752066 FDA UDI
- Description
- 45° Kelman®, 0.9 mm TurboSonics® Mini-Flared ABS® Tip FDA UDI45° Kelman®, 0.9 mm TurboSonics® ABS® Mini Tip FDA UDI30° Kelman®, 0.9 mm TurboSonics® Mini-Flared ABS® Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657508532 EUDAMEDFDA UDI00380657508525 EUDAMEDFDA UDI00380657520664 FDA UDI
- Basic UDI-DI
- 038065GMN000198HT EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Phacoemulsification system handpiece tip, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Angle — 45 degree FDA UDIOuter Diameter — 0.9 Millimeter FDA UDIAngle — 30 degree FDA UDI
Category: Phacoemulsification system handpiece tip, single-use
Alcon, Kelman, TurboSonics, Mini-Flared ABS by Alcon Laboratories, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification system handpiece tip, single-use.
- LAMINAR — Johnson & Johnson Surgical Vision, Inc. · Class II
- CANNULA — MED LOGICS INC · Class IIa
- Sterile Light Fibers — Vitreq B.V. · Class IIa
- 2.8 mm Disposable phaco set with 45° angled flared needle Note: Incision size 2. — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- AMO PHACO NEEDLE — Johnson & Johnson Surgical Vision, Inc. · Class II
- Sterile Ophthalmic Surgical Procedure Pack — Vitreq B.V. · Class IIa
- Sterile Viscous Fluid Injection / Extraction Tool — Vitreq B.V. · Class IIa
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (5)
- FDA UDI d6c33df3-1943-4302-b28a-cd7d7367f74d 35 fields · synced Jul 11, 2026
- FDA UDI a16c2289-6656-48c2-ba5e-3b5178c8e5ec 35 fields · synced May 24, 2026
- FDA UDI c31075b4-e7aa-42ab-b5e7-09d673508639 35 fields · synced May 30, 2026
- EUDAMED 95583506-ad7f-4e6a-b334-3e2c483e1266 61 fields · synced Jul 8, 2026
- EUDAMED 3676cd24-db10-4922-9be8-a582162cc426 61 fields · synced Jul 11, 2026