Identity
- Trade Name
- Skullerz FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- Skullerz OSMIN Anti-Scratch and Enhanced Anti-Fog Safety Glasses feature an Over-the-Glasses (OTG) wrap-around lens for a wide field of vision and seamless fit over prescription frames. These safety glasses feature tough anti-scratch and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The frame features a nylon and soft rubber design for added durability and flexibility, while a molded-in brow guard and side shields provide enhanced protection from debris. Integrated brow venting enables airflow for improved anti-fog performance. To provide a custom fit on a variety of faces, the rubber temples can be easily bent and re-bent for a custom, secure fit. Built-in soft rubber guards on the frame and temples protect prescription frames and lenses from constant movement and harmful scratching that can occur with some over-the-glass safety glasses. FDA UDI
- Model / Reference
- OSMIN-AFAS FDA UDI
- Description
- Skullerz OSMIN Anti-Scratch and Enhanced Anti-Fog Safety Glasses feature an Over-the-Glasses (OTG) wrap-around lens for a wide field of vision and seamless fit over prescription frames. These safety glasses feature tough anti-scratch and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The frame features a nylon and soft rubber design for added durability and flexibility, while a molded-in brow guard and side shields provide enhanced protection from debris. Integrated brow venting enables airflow for improved anti-fog performance. To provide a custom fit on a variety of faces, the rubber temples can be easily bent and re-bent for a custom, secure fit. Built-in soft rubber guards on the frame and temples protect prescription frames and lenses from constant movement and harmful scratching that can occur with some over-the-glass safety glasses. FDA UDI
Identifiers
- Catalog Number
- 55104 FDA UDI
- Primary DI / UDI-DI
- 00720476551041 FDA UDI
- FDA Product Code
- HQY FDA UDI
- GMDN Term
- Tinted non-prescription spectacles FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5850 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
No
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
Yes
FDA UDI
Category: Tinted non-prescription spectacles
Skullerz by Ergodyne — 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
- Ergodyne
Sources (1)
- FDA UDI 6ff0f5d2-a4e9-4553-8ef0-98be86a78792 34 fields · synced Jun 8, 2026