Identity
- Trade Name
- Anodyne Surgical FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Hydrodelineator 25g tapered to 30g tip, angled 4mm FDA UDI
- Model / Reference
- 7021 FDA UDI
- Description
- Hydrodelineator 25g tapered to 30g tip, angled 4mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516113227 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Anodyne Surgical by Psi/Eye-Ko, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
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- 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
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- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Ophthalmic Cannula — Katena Products, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Psi/Eye-Ko, Inc.
Sources (1)
- FDA UDI c15a5c6e-da1c-4050-8c78-c5f351388780 34 fields · synced Jun 1, 2026