Alcon

FDA UDI

Class II (US FDA UDI)

by Alcon Laboratories, Inc.

Identity

Trade Name: Alcon FDA UDI
Generic Name: Ophthalmic cannulation set, single-use FDA UDI
Device Name: 25 Ga Valved Trocar Cannula Entry System, 1 ct FDA UDI
Model / Reference: 8065751586 FDA UDI
Description: 25 Ga Valved Trocar Cannula Entry System, 1 ct FDA UDI

Identifiers

Primary DI / UDI-DI: 00380657515868 FDA UDI
FDA Product Code: HQC FDA UDI
HQE FDA UDI
GMDN Term: Ophthalmic cannulation set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4670 FDA UDI
886.4150 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Ophthalmic cannulation set, single-use

Alcon by Alcon Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic cannulation set, single-use.

Disposable One Step Cannula System (25 gauge/0.5 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Surgeon's Choice Card — OASIS Medical, Inc. · Class I
MANI Trocar Kit — MANI, INC. · Class I
Kaiser Permanente Kit Pack — OASIS Medical, Inc. · Class I
23G Cannula set with High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Disposable one step single cannula including inserter. (27 gauge / 0.4 mm) — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class I
Kaiser Permanente Kit Pack — OASIS Medical, Inc. · Class I
25G High Flow infusion line — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · 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 II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Alcon Laboratories, Inc.

Sources (1)

FDA UDI 496a067c-ccac-4c36-89fc-e085d856a460 35 fields · synced Jun 6, 2026