Lacrimal dilator, single-use

FDA UDI

Class I (US FDA UDI)

by Fci S A S Fci 20 22

Identity

Trade Name: Lacrimal dilator, single-use FDA UDI
Generic Name: Lacrimal dilator, single-use FDA UDI
Device Name: A sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device. FDA UDI
Model / Reference: DISPOSABLE PUNCTUM DILATOR AND PLUG INSERTER FDA UDI
Description: A sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device. FDA UDI

Identifiers

Catalog Number: S1.3090U FDA UDI
Primary DI / UDI-DI: 03760087120554 FDA UDI
FDA Product Code: HNW FDA UDI
GMDN Term: Lacrimal dilator, 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

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

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 133 Millimeter FDA UDI

Category: Lacrimal dilator, single-use

Lacrimal dilator, single-use by Fci S A S Fci 20 22 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Lacrimal dilator, single-use.

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Stephens Instruments — KRISHNA IMPORTS INC · Class I
LacriCATH — QUEST MEDICAL INC · U

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 33976bc1-c3d1-4b0a-8cc6-d42f6a352e8f 36 fields · synced May 30, 2026