Lasik Cannula 27g X 22mm (7/8”), formed
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Lasik Cannula 27g X 22mm (7/8”), formed EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Lasik Cannula 27g X 22mm (7/8”), formed FDA UDI
- Model / Reference
- Lasik Cannulas EUDAMED9901-9F EUDAMEDFDA UDI
- Description
- Lasik Cannula 27g X 22mm (7/8”), formed FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516106809 EUDAMED00840516118307 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840516199007D EUDAMED
- FDA Product Code
- GAA 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
- 878.4800 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
Lasik Cannula 27g X 22mm (7/8”), formed by Psi/Eye-Ko, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
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 | 0840516199007D | 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 (3)
- EUDAMED 988d862f-eb51-4046-86aa-e8c24d1feaa1 61 fields · synced Jul 24, 2026
- FDA UDI f44d03d1-d256-4231-9059-5be347f04984 34 fields · synced May 30, 2026
- EUDAMED 0686c044-1574-47d4-8b1a-4c8d387951d0 61 fields · synced Jul 24, 2026