Identity
- Trade Name
- Skullerz FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- Skullerz AEGIR Anti-Scratch and Enhanced Anti-Fog Safety Glasses feature an oversized blade-style design to provide superior eye protection and maximized field of vision. These protective safety glasses feature tough scratch-resistant and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The high-strength frame is built for durability and the rubberized nose bridge and temples offer non-slip security and resist sweat for all-day comfort. To provide a custom fit, the rubber temples can be easily bent and re-bent to accommodate a variety of head shapes and fit preferences. FDA UDI
- Model / Reference
- OSMIN FDA UDI
- Description
- Skullerz AEGIR Anti-Scratch and Enhanced Anti-Fog Safety Glasses feature an oversized blade-style design to provide superior eye protection and maximized field of vision. These protective safety glasses feature tough scratch-resistant and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The high-strength frame is built for durability and the rubberized nose bridge and temples offer non-slip security and resist sweat for all-day comfort. To provide a custom fit, the rubber temples can be easily bent and re-bent to accommodate a variety of head shapes and fit preferences. FDA UDI
Identifiers
- Catalog Number
- 55103 FDA UDI
- Primary DI / UDI-DI
- 00720476551034 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 063ec401-46f0-4f52-99da-aba4253031e7 34 fields · synced May 30, 2026