Small Parts Kit (Bulk Non-Sterile)
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Alcon FDA UDI
- Generic Name
- Ophthalmic surgical procedure kit, non-medicated, single-use FDA UDI
- Device Name
- Small Parts Kit (Bulk Non-Sterile) EUDAMEDSmall Parts Kit (Sterile) EUDAMEDNano Sleeves Small Parts Kit FDA UDI
- Model / Reference
- 8065750360 EUDAMED8065000470 EUDAMED8065751526 EUDAMED00380650004703 FDA UDI
- Description
- Nano Sleeves Small Parts Kit FDA UDI
Identifiers
- Catalog Number
- 8065000470 FDA UDI
- Primary DI / UDI-DI
- 00380657503605 EUDAMED00380650004703 EUDAMEDFDA UDI00380657515264 EUDAMED
- Basic UDI-DI
- 038065GMN000300GS EUDAMED038065GMN000197HR EUDAMED
- FDA Product Code
- NGY 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 I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Phacoemulsification system handpiece tip, single-use
Small Parts Kit (Bulk Non-Sterile) by Alcon Laboratories, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Phacoemulsification system handpiece tip, single-use.
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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 | 038065GMN000300GS | 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 (4)
- EUDAMED ffb1787a-50c7-4464-938c-9ecb367c111e 61 fields · synced Jul 13, 2026
- FDA UDI 82138341-f29b-4a0a-a7e5-9f1ef9b0acdf 34 fields · synced May 30, 2026
- EUDAMED 287533ff-1df8-4f68-ae98-37b2cc6aed0a 61 fields · synced Jul 9, 2026
- EUDAMED c407d066-5a31-4a32-ba0d-2125b3b4bb39 61 fields · synced Jul 11, 2026