Identity
- Trade Name
- High Pressure Extension Tube 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. EUDAMEDHigh Pressure Extension Tube FDA UDI
- Model / Reference
- 3243 EUDAMEDFDA UDI
- Description
- High Pressure Extension Tube FDA UDI
Identifiers
- Catalog Number
- 3243 FDA UDI
- Primary DI / UDI-DI
- 00811313012433 EUDAMED10811313012430 FDA UDI
- Basic UDI-DI
- 081131301MEDSURG01QY EUDAMED
- Direct Marketing DI
- 00811313012433 EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
High Pressure Extension Tube by MedOne Surgical, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 aad8c5ef-a984-4458-b225-a3a7b78b8f1c 61 fields · synced Jul 18, 2026
- FDA UDI d8beb243-1479-4b69-92a9-0ae389fd35b7 35 fields · synced May 30, 2026