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Anodyne Surgical
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 8215Model Manual Handled Instruments
Identity
- Trade Name
- Push – Pull Manipulator angled EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic surgical probe, single-use FDA UDI
- Device Name
- Push – Pull Manipulator angled FDA UDI
- Model / Reference
- 8215 EUDAMEDFDA UDIManual Handled Instruments EUDAMED
- Description
- Push – Pull Manipulator angled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516117614 EUDAMEDFDA UDI
- Basic UDI-DI
- 08405161820063 EUDAMED
- FDA Product Code
- HNQ FDA UDI
- EMDN Code
- Q021104 OPHTHALMIC SURGERY MANIPULATORS, SINGLE-USE EUDAMED
- GMDN Term
- Ophthalmic surgical probe, 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
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: Ophthalmic surgical probe, single-use
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 a8c2bf40-693e-4d23-aa64-d41df75a87dc 34 fields · synced Jun 19, 2026
- EUDAMED 6fc4fa76-2083-474c-9891-0d870865bb37 61 fields · synced Jun 19, 2026