Active/Passive backflush handle with soft-tip cannula.
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Handpieces and Cannulae FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Active/Passive backflush handle with soft-tip cannula. EUDAMEDAct/Pass Backflush 25g FDA UDI
- Model / Reference
- Handpieces and Cannulae EUDAMEDM4504-02/5 EUDAMEDFDA UDI
- Description
- Act/Pass Backflush 25g FDA UDI
Identifiers
- Catalog Number
- M4504 FDA UDI
- Primary DI / UDI-DI
- 15056030403023 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560304F12-IY3 EUDAMED
- FDA Product Code
- MED 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 II FDA UDI
- Regulation Number
- 880.6885 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
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
Yes
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Active/Passive backflush handle with soft-tip cannula. by Sterimedix Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50560304F12-IY3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sterimedix Ltd
- EUDAMED SRN
- GB-MF-000011604
- Authorised Representative
- Bausch & Lomb GmbH DE-AR-000006810
Sources (2)
- EUDAMED 8e08e6eb-6023-4c81-ae23-8f7715002e8d 61 fields · synced Jun 17, 2026
- FDA UDI 80f7cd31-c56e-4593-92b8-e6a0e1215ffb 34 fields · synced May 30, 2026