Opti-Gard

FDA UDI

Class I (US FDA UDI)

by Dupaco, Inc.

Identity

Trade Name: Opti-Gard FDA UDI
Generic Name: Eye splash shield, single-use FDA UDI
Device Name: Opti-Gard LARGE CE NON-STERILE PACK FDA UDI
Model / Reference: D28300CE FDA UDI
Description: Opti-Gard LARGE CE NON-STERILE PACK FDA UDI

Identifiers

Catalog Number: D28300CE FDA UDI
Primary DI / UDI-DI: 10850017419046 FDA UDI
FDA Product Code: HOY FDA UDI
IWS FDA UDI
GMDN Term: Eye splash shield, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4750 FDA UDI
892.6500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Category: Eye splash shield, single-use

Opti-Gard by Dupaco, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Dupaco, Inc.

Sources (1)

FDA UDI 0d2f9c5d-45c1-4164-9066-567d3e85ce67 36 fields · synced Jun 8, 2026