Identity
- Trade Name
- DualBore SideFlō® Cannula 27g EUDAMEDMedOne FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Sterile cannula family of medical devices - cannulae, brushes, picks and related accessories (tubing, backflush devices and injection kits) for ophthalmic use. EUDAMEDDualBore SideFlo® Cannula 27g FDA UDI
- Model / Reference
- 3427 EUDAMEDFDA UDI
- Description
- DualBore SideFlo® Cannula 27g FDA UDI
Identifiers
- Catalog Number
- 3427 FDA UDI
- Primary DI / UDI-DI
- 00811313014277 EUDAMED10811313014274 FDA UDI
- Basic UDI-DI
- 081131301MEDSURG01QY EUDAMED
- Direct Marketing DI
- 00811313014277 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
MedOne by MedOne Surgical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Universal PVC infusion line for 23G cannula system for VFI/VFE — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Soft Tip Cannula 20g, 0.8mm tip — Psi/Eye-Ko, Inc. · Class IIa
- I/A HDP. 45 W SLEEVE 1.8 12/BX — Bausch & Lomb, Inc. · Class II
- Visitec® — Beaver-Visitec International, Inc. · Class I
- 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
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MedOne Surgical, Inc.
Sources (2)
- FDA UDI 5e550190-2afb-4fdd-929c-6682c62686fd 35 fields · synced Jul 9, 2026
- EUDAMED 8473d516-3ac3-445a-87f1-a13fe7651a64 61 fields · synced Jul 9, 2026