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Alcon, TurboSonics, ABS, MicroTip
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 8065740837Ref 8065750261Ref 8065740806
Identity
- Trade Name
- TurboSonics , ABS , MicroTip EUDAMEDTurboSonics , ABS EUDAMEDAlcon, TurboSonics, ABS, MicroTip FDA UDIAlcon, TurboSonics, Flared ABS FDA UDIAlcon, TurboSonics, Flared ABS, MicroTip FDA UDIAlcon, TurboSonics, Tapered 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® ABS® MicroTip™ Tip FDA UDI30° Round, 1.1mm TurboSonics® Flared ABS® Tip FDA UDI30° Round, 0.9 mm TurboSonics® Flared ABS® MicroTip™ Tip FDA UDI30° Round, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip FDA UDI
- Model / Reference
- 8065740806 EUDAMEDFDA UDI8065740837 EUDAMEDFDA UDI8065750261 EUDAMEDFDA UDI8065790023 FDA UDI
- Description
- 45° Kelman®, 0.9 mm TurboSonics® ABS® MicroTip™ Tip FDA UDI30° Round, 1.1mm TurboSonics® Flared ABS® Tip FDA UDI30° Round, 0.9 mm TurboSonics® Flared ABS® MicroTip™ Tip FDA UDI30° Round, 0.9 mm TurboSonics® Tapered ABS® MicroTip™ Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00380657408061 EUDAMEDFDA UDI00380657408375 EUDAMEDFDA UDI00380657502615 EUDAMEDFDA UDI00380657900237 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
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 UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 45 degree FDA UDIOuter Diameter — 0.9 Millimeter FDA UDIOuter Diameter — 1.1 Millimeter FDA UDIAngle — 30 degree FDA UDI
Category: Phacoemulsification system handpiece tip, single-use
Alcon, TurboSonics, ABS, MicroTip 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 (7)
- FDA UDI 1b14c955-d466-49f6-939c-ffc9d08158b4 35 fields · synced Jul 21, 2026
- FDA UDI 361f0c6b-4c1e-4412-8b8c-7ef8793d9f6b 35 fields · synced May 30, 2026
- FDA UDI 0087dce2-1903-4f90-b7ac-dcc486db0460 35 fields · synced May 30, 2026
- FDA UDI 3a350028-52b7-4c5f-bb18-154eed8895d4 35 fields · synced May 30, 2026
- EUDAMED 12eb8e43-0d08-48ae-b2f5-74b4663822f9 61 fields · synced Jul 12, 2026
- EUDAMED ea24ecb9-420f-497a-8138-bab69c22de91 61 fields · synced Jul 18, 2026
- EUDAMED fa8cfff7-4132-472f-b798-b8e0788c473a 61 fields · synced Jul 21, 2026