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Anodyne Surgical
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 8000-26(32)Model Lacrimal cannulas
Identity
- Trade Name
- Lacrimal Cannula 26g X 32mm (1 1/4"), curved EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Lacrimal procedural cannula FDA UDI
- Device Name
- Lacrimal Cannula 26g X 32mm (1 1/4"), curved FDA UDI
- Model / Reference
- 8000-26(32) EUDAMEDFDA UDILacrimal cannulas EUDAMED
- Description
- Lacrimal Cannula 26g X 32mm (1 1/4"), curved FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516117461 EUDAMEDFDA UDI
- Basic UDI-DI
- 0840516180005R EUDAMED
- FDA Product Code
- HMX FDA UDI
- EMDN Code
- Q021101 OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE EUDAMED
- GMDN Term
- Lacrimal procedural cannula 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
No
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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lacrimal procedural cannula
Anodyne Surgical by Psi/Eye-Ko, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Psi/Eye-Ko, Inc.
Sources (2)
- FDA UDI 77d953c0-ef32-47c9-8509-c90f160e0067 34 fields · synced Sep 18, 2026
- EUDAMED 2ac2c605-51cf-44bd-bf8e-0fb62b280806 61 fields · synced Sep 18, 2026