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Alcon, Ozil, TurboSonics, Mini-Flared ABS
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 8065751176Ref 8065000215
Identity
- Trade Name
- TurboSonics , ABS , OZIL EUDAMEDOzil EUDAMEDAlcon, Ozil, TurboSonics, Mini-Flared ABS FDA UDIUNITY FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, single-use FDA UDIVitrectomy system handpiece FDA UDI
- Device Name
- TurboSonics U/S Tips EUDAMEDPhacoemulsification Handpieces EUDAMED45° OZil® 12, 0.9 mm TurboSonics® Mini-Flared ABS® Tip FDA UDIOZIL Fragmentation Handpiece FDA UDI30° OZil® 12, 0.9 mm TurboSonics® Mini-Flared ABS® Tip FDA UDI
- Model / Reference
- 8065751176 EUDAMEDFDA UDI8065000215 EUDAMED8065751177 FDA UDI00380650002150 FDA UDI
- Description
- 45° OZil® 12, 0.9 mm TurboSonics® Mini-Flared ABS® Tip FDA UDIOZIL Fragmentation Handpiece FDA UDI30° OZil® 12, 0.9 mm TurboSonics® Mini-Flared ABS® Tip FDA UDI
Identifiers
- Catalog Number
- 8065000215 FDA UDI
- Primary DI / UDI-DI
- 00380650002150 EUDAMEDFDA UDI00380657511761 EUDAMEDFDA UDI00380657511778 FDA UDI
- Basic UDI-DI
- 038065GMN000198HT EUDAMED038065GMN000068HD EUDAMED
- Direct Marketing DI
- 00380650002150 EUDAMED
- FDA Product Code
- HQC FDA UDIHQE FDA UDI
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMEDZ1212020780 PHACO-VITRECTOMY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Phacoemulsification system handpiece tip, single-use FDA UDIVitrectomy system handpiece FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI886.4150 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMEDEUDAMED
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 UDIFDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
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, Ozil, TurboSonics, Mini-Flared ABS by Alcon Laboratories, Inc. — 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
- Alcon Laboratories, Inc.
Sources (5)
- FDA UDI 2ea75170-4751-427f-8885-c23a409c88f1 35 fields · synced Jul 10, 2026
- FDA UDI ff49b82c-b996-47d4-95b5-431ed679b328 34 fields · synced May 30, 2026
- FDA UDI 9f5e7eeb-2304-4faa-92b9-fa26f77361d7 35 fields · synced May 30, 2026
- EUDAMED bc7c510e-5943-46ae-86f0-6556bf1f6c2c 61 fields · synced Jul 10, 2026
- EUDAMED 253c0013-6383-4fdb-b7f8-c57a68ec8d96 61 fields · synced Jul 10, 2026