GUDIDData
gudid Primary ID: Oxfore100

Oxfore100 (UDI Oxfore100)

Manufactured by Paragon Vision Sciences, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Oxfore100 - Primary ID Oxfore100

Device Regulatory Overview

The Oxfore100 (Model/Catalog Number: Oxfore100) is a medical device manufactured by Paragon Vision Sciences, Inc.. This product is indexed under FDA Product Code / Category Classification HQD within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
Oxfore100
Product Code / EMDN
HQD
Device Name
The Oxfore100 (hexafocon A) Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses lathe cut into the following designs:SphericalAsphericalToricMulifocal Scleral Semi-scleral Oxfore100 (hexafocon A) may incorporate an ultraviolet light absorber and is available in a variety of tints. The material (hexafocon A) from which these lenses are made and the contact lenses described herein are substantially equivalent to the Boston XO (hexafocon A) Material and Contact Lenses described in K171404.These devices will not be marketed with multiple components or any required accessories.
Database Sync Date
2026-08-09 09:43:50

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of Oxfore100?

The registered manufacturer of record for Oxfore100 is Paragon Vision Sciences, Inc..

What is the Primary UDI-DI identifier for Oxfore100?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Oxfore100.

What classification code is assigned to this device?

This device is registered under product classification code HQD.

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