Identity
- Trade Name
- Skullerz FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- Skullerz OSMIN 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 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 all-day comfort. 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 FDA UDI
- Description
- Skullerz OSMIN 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 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 all-day comfort. 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
- 55101 FDA UDI
- Primary DI / UDI-DI
- 00720476551010 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 ee305a74-8b66-490a-ace9-d0da22b44416 34 fields · synced Jun 6, 2026