Identity
- Trade Name
- Skullerz FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- Skullerz AEGIR Safety Glasses feature an oversized blade-style design to provide superior eye protection and maximized field of vision. These protective safety glasses feature 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
- AEGIR FDA UDI
- Description
- Skullerz AEGIR Safety Glasses feature an oversized blade-style design to provide superior eye protection and maximized field of vision. These protective safety glasses feature 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
- 55001 FDA UDI
- Primary DI / UDI-DI
- 00720476550013 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 aa4942ae-2b8c-4f2e-9d0f-762eed2aa01b 34 fields · synced May 30, 2026