Identity
- Trade Name
- Cannula 20g EUDAMEDMedOne FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Viscous Fluid Cannula 20g (4mm) EUDAMEDCannula 20g FDA UDI
- Model / Reference
- 3200 EUDAMED3214 EUDAMEDFDA UDI
- Description
- Cannula 20g FDA UDI
Identifiers
- Catalog Number
- 3214 FDA UDI
- Primary DI / UDI-DI
- 00811313012143 EUDAMED10811313012140 FDA UDI
- Basic UDI-DI
- 081131301MEDSURG01QY EUDAMED
- Direct Marketing DI
- 00811313012143 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
- Austria 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
Yes
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
No
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Cannula 20g by MedOne Surgical, 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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- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081131301MEDSURG01QY | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- MedOne Surgical, Inc.
- EUDAMED SRN
- US-MF-000002763
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 5f0f9771-44fb-4ecc-b083-f4a550930140 61 fields · synced Jun 17, 2026
- FDA UDI 41b8d285-d3a3-40f0-8a60-f6fdb7ef20f5 35 fields · synced May 30, 2026