Identity
- Trade Name
- UNITY EUDAMEDFDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Fragmentation Packs EUDAMED22GA Fragmentation Pack FDA UDI
- Model / Reference
- 8065000125 EUDAMED00380650001252 FDA UDI
- Description
- 22GA Fragmentation Pack FDA UDI
Identifiers
- Catalog Number
- 8065000125 FDA UDI
- Primary DI / UDI-DI
- 00380650001252 EUDAMEDFDA UDI
- Basic UDI-DI
- 038065GMN000072H4 EUDAMED
- FDA Product Code
- HQE FDA UDI
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4150 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
Yes
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
Yes
Category: Phacoemulsification system handpiece tip, single-use
Unity by Alcon Laboratories, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038065GMN000072H4 | 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 8fe0b47f-0fa2-48f7-9cc6-8a23ebae10c1 61 fields · synced May 30, 2026
- FDA UDI 505a7b30-4faf-400e-bbae-c1d85bcaf6c4 35 fields · synced May 29, 2026