Anterior Chamber Cannula Thin Wall 25g X 10mm bend
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Anterior Chamber Cannula Thin Wall 25g X 10mm bend EUDAMEDAnterior Chamber Cannula 25g X 10mm bend EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Anterior Chamber Cannula 25g X 10mm bend FDA UDI
- Model / Reference
- Anterior Chamber Cannulas Thin Wall EUDAMED2003-10 EUDAMED1003-10 EUDAMEDFDA UDIAnterior Chamber Cannulas EUDAMED
- Description
- Anterior Chamber Cannula 25g X 10mm bend FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516104614 EUDAMED00840516115245 EUDAMEDFDA UDI00840516103952 EUDAMED
- Basic UDI-DI
- 0840516120004F EUDAMED08405161100048 EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- France 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
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Anterior Chamber Cannula Thin Wall 25g X 10mm bend by Psi/Eye-Ko, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, 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 | 0840516120004F | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- PSI/EYE-KO, Inc.
- EUDAMED SRN
- US-MF-000022109
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (4)
- EUDAMED f2a31f49-3c9c-4fcb-a7e3-aacf314908b1 61 fields · synced Jul 29, 2026
- FDA UDI 252046d4-f16c-41c6-81ec-00bdc2422102 34 fields · synced May 30, 2026
- EUDAMED f3b8aca1-582b-4103-8b13-2ea4f5dbd3a0 61 fields · synced Jul 9, 2026
- EUDAMED d617c30c-0f38-40f3-b8b5-0a189c9ad27b 61 fields · synced Jul 29, 2026