Anodyne Surgical
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Button Tip Manipulator, angled EUDAMEDAnodyne Surgical FDA UDI
- Generic Name
- Ophthalmic surgical probe, single-use FDA UDI
- Device Name
- Button Tip Manipulator, angled FDA UDI
- Model / Reference
- 8202 EUDAMEDFDA UDIManual Handled Instruments EUDAMED
- Description
- Button Tip Manipulator, angled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516117546 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
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 surgical probe, single-use
A reliable and effective button tip manipulator for ophthalmic procedures. With its sleek design and precise mechanism, this device is perfect for delicate tasks.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 2808b023-7220-4d04-96d5-0bcff35d04e7 34 fields · synced Jul 25, 2026
- EUDAMED 9677ed72-7cb4-4f5a-8452-230daebba541 61 fields · synced Jul 25, 2026