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 neoprene strap is adjustable, comfortably secures on heads, hard hats or caps and is easy to clean when the job gets dirty. FDA UDI
- Model / Reference
- ARKYN-NEO 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 neoprene strap is adjustable, comfortably secures on heads, hard hats or caps and is easy to clean when the job gets dirty. FDA UDI
Identifiers
- Catalog Number
- 60311 FDA UDI
- Primary DI / UDI-DI
- 00720476603115 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 839ba48b-2b0f-491b-bd8f-41cbb8601996 34 fields · synced May 30, 2026