Identity
- Trade Name
- UVEX FDA UDI
- Generic Name
- Phototherapy eye protector, reusable FDA UDI
- Device Name
- Uvex Ultra Spec protective eyewear to protect eyes from powerful light sources being used in offices. These glasses can be used with your prescription eyewear. FDA UDI
- Model / Reference
- SGU FDA UDI
- Description
- Uvex Ultra Spec protective eyewear to protect eyes from powerful light sources being used in offices. These glasses can be used with your prescription eyewear. FDA UDI
Identifiers
- Catalog Number
- SGU FDA UDI
- Primary DI / UDI-DI
- D798SGU0 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Phototherapy eye protector, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Phototherapy eye protector, reusable
Uvex by Reliance Orthodontic Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Phototherapy eye protector, reusable.
- NeoShades® with Headstrap Phototherapy Eye Shields - Micro Plain — Neotech Products LLC · Class I
- NeoShades® with Tabs Phototherapy Eye Shields - Small Plain — Neotech Products LLC · Class I
- Sahil Surgical (Pvt) Ltd — Sahil Surgical (Pvt) Ltd. · Class I
- PHOTOTHERAPY MASKS (Pack of 50) — GINEVRI srl · Class I
- EyeMax2 — Maxtec, Inc. · Class I
- VER-FIX Dwuczęściowe okularki do fototerapii — SINMED SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ · Class I
- WeeSpecs Supreme, Medium, 50/pk — INTERNATIONAL BIOMEDICAL, LTD. · Class I
- Phototherapy Eye Band Large — Dilamed Tıbbi Ürünler Sanayi ve Ticaret A.Ş. · Class I
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
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 004c543c-ad80-4f8e-9303-a616d6d0c47f 36 fields · synced May 31, 2026