Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- TurboSonics , ABS , MicroTip , Kelman EUDAMEDAlcon, Kelman, TurboSonics, Tapered ABS, MicroTip FDA UDIAlcon, TurboSonics, ABS, MicroTip FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, single-use FDA UDI
- Device Name
- TurboSonics U/S Tips EUDAMED45° Kelman®, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip FDA UDI30° Kelman®, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip FDA UDI30° Kelman®, 0.9 mm TurboSonics® ABS® MicroTip™ Tip FDA UDI
- Model / Reference
- 8065750263 EUDAMEDFDA UDI8065790022 EUDAMEDFDA UDI8065750264 FDA UDI
- Description
- 45° Kelman®, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip FDA UDI30° Kelman®, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip FDA UDI30° Kelman®, 0.9 mm TurboSonics® ABS® MicroTip™ Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657502639 EUDAMEDFDA UDI00380657900220 EUDAMEDFDA UDI00380657502646 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
- Outer Diameter — 0.9 Millimeter FDA UDIAngle — 45 degree FDA UDIAngle — 30 degree FDA UDI
Category: Phacoemulsification system handpiece tip, single-use
Alcon, Kelman, TurboSonics, Tapered ABS, MicroTip by Alcon Laboratories, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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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 |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (5)
- FDA UDI 354dd5d0-7e86-403d-9c93-cd11bbab629a 35 fields · synced Jul 15, 2026
- FDA UDI 3bf23b01-47bc-419d-ab4a-0af54089dc06 35 fields · synced May 30, 2026
- FDA UDI a963f626-8a7e-4ed7-93c6-791b0a5315d5 35 fields · synced May 30, 2026
- EUDAMED 50ab5875-f168-416c-97a2-4816a402d3f9 61 fields · synced Jun 20, 2026
- EUDAMED 23d020c3-3dfb-4a2b-ad8a-d7a1aa4af064 61 fields · synced Jul 15, 2026