Arbisser A/C Manager Angled 30g
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Arbisser A/C Manager Angled 30g EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Arbisser A/C Manager Angled 30g FDA UDI
- Model / Reference
- Anterior Chamber Cannulas EUDAMED1000A EUDAMEDFDA UDI
- Description
- Arbisser A/C Manager Angled 30g FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516103518 EUDAMED00840516114996 EUDAMEDFDA UDI
- Basic UDI-DI
- 08405161100048 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
- 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
Arbisser A/C Manager Angled 30g 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.
- Universal PVC infusion line for 23G cannula system for VFI/VFE — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- 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
- SURGISTAR — Surgistar Inc. · Class I
- Lasik Irrigator - 4 Ports — Hurricane Medical · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Ophthalmic Cannula — Katena Products, 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 | 08405161100048 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PSI/EYE-KO, Inc.
- EUDAMED SRN
- US-MF-000022109
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 2322972f-4382-4b22-9620-ee0d08ba5813 61 fields · synced Jul 30, 2026
- FDA UDI 09b41c00-6e77-49ec-96b1-b668fbf6581d 34 fields · synced May 25, 2026
- EUDAMED cd736f68-b877-4419-8e1c-2245f5d9c0c1 61 fields · synced Jul 30, 2026