Identity
- Trade Name
- FINESSE EUDAMEDAlcon Greishaber Finesse FDA UDI
- Generic Name
- Epiretinal/inner limiting membrane scraper, single-use FDA UDI
- Device Name
- Ophthalmic manipulators DSP EUDAMED23G FINESSE® Flex Loop DSP FDA UDI
- Model / Reference
- 338.23 EUDAMEDFDA UDI
- Description
- 23G FINESSE® Flex Loop DSP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07612717071421 EUDAMEDFDA UDI
- Basic UDI-DI
- 038065GMN000154H7 EUDAMED
- FDA Product Code
- HNQ FDA UDI
- EMDN Code
- Q021104 OPHTHALMIC SURGERY MANIPULATORS, SINGLE-USE EUDAMED
- GMDN Term
- Epiretinal/inner limiting membrane scraper, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic surgical probe, single-use
Finesse by Alcon Laboratories, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic surgical probe, single-use.
- HASA OPTIX — Hasa Optix · Class IIa
- HASA OPTIX — Hasa Optix · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- HASA OPTIX — Hasa Optix · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- HASA OPTIX — Hasa Optix · Class IIa
- Epithelial Spatula — BLINK MEDICAL LIMITED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038065GMN000154H7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
- EUDAMED SRN
- US-MF-000016248
- Authorised Representative
- Alcon Laboratories Belgium BE-AR-000014721
Sources (2)
- EUDAMED 82be8e4c-fbc4-41ba-9338-26464de3d256 61 fields · synced Jul 25, 2026
- FDA UDI 731163e8-8c14-4179-b756-1298bc3b36bb 34 fields · synced May 30, 2026