Skullerz
Basic Information
- Brand Name
- Skullerz
- Primary DI
- 00720476551041
- Version / Model
- OSMIN-AFAS
- Catalog Number
- 55104
- Company Name
- Ergodyne
- Labeler DUNS
- 108665142
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-22
- Public Version
- 1
- Public Version Date
- 2023-08-30
- Public Version Status
- New
- Public Device Record Key
- 6ff0f5d2-a4e9-4553-8ef0-98be86a78792
Device Description
Skullerz OSMIN Anti-Scratch and Enhanced Anti-Fog Safety Glasses feature an Over-the-Glasses (OTG) wrap-around lens for a wide field of vision and seamless fit over prescription frames. These safety glasses feature tough anti-scratch and anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. The frame features a nylon and soft rubber design for added durability and flexibility, while a molded-in brow guard and side shields provide enhanced protection from debris. Integrated brow venting enables airflow for improved anti-fog performance. To provide a custom fit on a variety of faces, the rubber temples can be easily bent and re-bent for a custom, secure fit. Built-in soft rubber guards on the frame and temples protect prescription frames and lenses from constant movement and harmful scratching that can occur with some over-the-glass safety glasses.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQY | Sunglasses (Non-Prescription Including Photosensitive) | Ophthalmic | 886.5850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 39694 | Tinted non-prescription spectacles | An optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00720476551041 | GS1 |