Identity
- Trade Name
- Anodyne Surgical FDA UDI
- Generic Name
- Lacrimal dilator, reusable FDA UDI
- Device Name
- Castroviejo Lachrymal Dilator DBL Ended Size 1&2, Round Handle, 120mm Length, SS FDA UDI
- Model / Reference
- CN2001 FDA UDI
- Description
- Castroviejo Lachrymal Dilator DBL Ended Size 1&2, Round Handle, 120mm Length, SS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840516131337 FDA UDI
- FDA Product Code
- HNW FDA UDI
- GMDN Term
- Lacrimal dilator, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Lacrimal dilator, reusable
Anodyne Surgical by Psi/Eye-Ko, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Lacrimal dilator, reusable.
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- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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 088847a5-a1e6-47ab-a1d4-1494ce68716c 34 fields · synced May 30, 2026