SOFT PLUG® Collagen Intracanalicular Plugs

FDA UDI

Class U (US FDA UDI)

by OASIS Medical, Inc.

Identity

Trade Name: SOFT PLUG® Collagen Intracanalicular Plugs FDA UDI
Generic Name: Lacrimal punctum plug FDA UDI
Device Name: Temporary Collagen Implant [PluG] [BVI] 0.4mm Dia x 2.0mm Long FDA UDI
Model / Reference: A12-104 FDA UDI
Description: Temporary Collagen Implant [PluG] [BVI] 0.4mm Dia x 2.0mm Long FDA UDI

Identifiers

Primary DI / UDI-DI: 10845819005412 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

Radiation Sterilization FDA UDI

Category: Lacrimal punctum plug

SOFT PLUG® Collagen Intracanalicular Plugs by OASIS Medical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 2edf3ec4-0e88-4e7a-b876-15bf5391f9fc 34 fields · synced Jun 9, 2026