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Opti-Gard

FDA UDI

Class I (US FDA UDI)

by Dupaco, Inc.

Identity

Trade Name
Opti-Gard FDA UDI
Generic Name
Radiation shielding goggles/spectacles FDA UDI
Device Name
LASER OPTI-GARD LARGE NON-STERILE PACK FDA UDI
Model / Reference
D28400 FDA UDI
Description
LASER OPTI-GARD LARGE NON-STERILE PACK FDA UDI

Identifiers

Catalog Number
D28400 FDA UDI
Primary DI / UDI-DI
10850017419077 FDA UDI
FDA Product Code
HOY FDA UDI
IWS FDA UDI
GMDN Term
Radiation shielding goggles/spectacles 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiation shielding goggles/spectacles

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

Similar devices

Also classified as Radiation shielding goggles/spectacles.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dupaco, Inc.

Sources (1)

  • FDA UDI d76be215-dc82-4427-ab11-a53567ecaf9e 36 fields · synced May 29, 2026