Identity
- Trade Name
- Skullerz FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- The Skullerz ARKYN Anti-Scratch and Enhanced Anti-Fog Safety Goggles are low-profile and lightweight in design with a wrap-around lens for a wide field of vision. These protective safety goggles feature tough anti-scratch and anti-fog polycarbonate lenses to provide a clear vision and protect eyes from flying dust, particles, droplets and splashes in tough work environments. The soft gasket lining forms to the wearer’s face for a comfortable, customized fit while sealing out dust, debris and liquid splashes. The soft, woven elastic strap is adjustable and comfortably secures on heads, hard hats or caps. FDA UDI
- Model / Reference
- ARKYN-FAB FDA UDI
- Description
- The Skullerz ARKYN Anti-Scratch and Enhanced Anti-Fog Safety Goggles are low-profile and lightweight in design with a wrap-around lens for a wide field of vision. These protective safety goggles feature tough anti-scratch and anti-fog polycarbonate lenses to provide a clear vision and protect eyes from flying dust, particles, droplets and splashes in tough work environments. The soft gasket lining forms to the wearer’s face for a comfortable, customized fit while sealing out dust, debris and liquid splashes. The soft, woven elastic strap is adjustable and comfortably secures on heads, hard hats or caps. FDA UDI
Identifiers
- Catalog Number
- 60313 FDA UDI
- Primary DI / UDI-DI
- 00720476603139 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 a64cb350-8691-4580-929f-d1fdb47a69dc 34 fields · synced Jun 1, 2026