SOFT PLUG® Extended Duration Plugs

FDA UDI

Class U (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name: SOFT PLUG® Extended Duration Plugs FDA UDI
Generic Name: Lacrimal punctum plug FDA UDI
Device Name: SOFT PLUG® Extended Duration Plug, 0.2mm DIA x 2mm Long FDA UDI
Model / Reference: 6402, 6402-A FDA UDI
Description: SOFT PLUG® Extended Duration Plug, 0.2mm DIA x 2mm Long FDA UDI

Identifiers

Primary DI / UDI-DI: 10845819000219 FDA UDI
FDA Product Code: LZU FDA UDI
GMDN Term: Lacrimal punctum plug FDA UDI

Classification

Device Class: U 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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Lacrimal punctum plug

Soft Plug Extended Duration Plugs are a type of sterile, implantable device designed to prevent tear outflow in dry eye patients. These plugs are inserted into the lacrimal punctum and come with various features such as [map[code:LZU name:Plug, Punctum openfda:map[device_class:U device_name:Plug, Punctum medical_specialty_description:Unknown regulation_number:]] and a unique identifier of 194121018. The plugs are compliant with FDA regulations and have undergone sterilization using Ethylene Oxide. They are available for commercial distribution in the US and can be used to treat dry eye patients. For more information on this device, please contact our customer service team at [email:[email protected] phone:9093055400].

Similar devices

Also classified as Lacrimal punctum plug.

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Stephens Instruments — KRISHNA IMPORTS INC · U
Lacrivera — STEPHENS INSTRUMENTS, INC · Class IIb
TearSaver® - 0.7 mm — FCI S A S FCI 20 22 · 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 U	Pending data

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Manufacturer

Manufacturer: OASIS Medical, Inc.

Sources (1)

FDA UDI acc58869-74e8-4964-8110-e4e7b12bcac6 34 fields · synced Jul 9, 2026