Identity
- Trade Name
- Skullerz FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- Skullerz BALDR Safety Glasses feature a full-frame design and non-slip rubber temples to keep glasses secure, while also resisting sweat. These safety glasses feature polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. Available in a variety of lenses to suit a range of tasks and light environments. The durable frames bend and flex without breaking. The integrated accessory receptors at each temple also improve airflow when not in use. For added safety, an elastic retainer strap or foam gasket insert (both sold separately) can be attached to the temples. FDA UDI
- Model / Reference
- BALDR FDA UDI
- Description
- Skullerz BALDR Safety Glasses feature a full-frame design and non-slip rubber temples to keep glasses secure, while also resisting sweat. These safety glasses feature polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. Available in a variety of lenses to suit a range of tasks and light environments. The durable frames bend and flex without breaking. The integrated accessory receptors at each temple also improve airflow when not in use. For added safety, an elastic retainer strap or foam gasket insert (both sold separately) can be attached to the temples. FDA UDI
Identifiers
- Catalog Number
- 57000 FDA UDI
- Primary DI / UDI-DI
- 00720476570004 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 b85c7bc3-e690-4ed0-ad36-474d5ee15cc1 34 fields · synced Jun 8, 2026