Identity
- Trade Name
- Lacrimal dilator, reusable FDA UDI
- Generic Name
- Lacrimal dilator, reusable FDA UDI
- Device Name
- A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device. FDA UDI
- Model / Reference
- DOUBLE DILATOR FDA UDI
- Description
- A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- A8.4050 FDA UDI
- Primary DI / UDI-DI
- 03760087126075 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
Yes
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 119 Millimeter FDA UDI
Category: Lacrimal dilator, reusable
Lacrimal dilator, reusable by Fci S A S Fci 20 22 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lacrimal dilator, reusable.
- V. Mueller — STERIS CORPORATION · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Surgitrac — Sihong Surgitrac Co., Ltd · Class IIa
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Anodyne Surgical — Psi/Eye-Ko, 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
- Fci S A S Fci 20 22
Sources (1)
- FDA UDI 72c9b2de-583a-4a9b-8fc5-674a0c084fa2 36 fields · synced May 30, 2026