Skullerz

Basic Information

• Brand Name: Skullerz
• Primary DI: 00720476591832
• Version / Model: SAGA-AF
• Catalog Number: 59183
• Company Name: Ergodyne
• Labeler DUNS: 108665142
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-29
• Public Version: 1
• Public Version Date: 2023-09-06
• Public Version Status: New
• Public Device Record Key: dc42ead5-0f67-4ba2-b213-96e71145a53b

Device Description

Skullerz SAGA Anti-Fog Safety Glasses feature a sleek and sporty frameless design and offer a wide field of vision, while a variety of lens options can be matched to your specific task and light environment. These safety glasses feature tough anti-fog polycarbonate lenses to protect against impacts and filter 99.9 percent of harmful UVA, UVB and UVC rays. A contoured nose bridge provides a comfortable fit that won’t slip or pinch. Flex-fit and non-slip temples reduce pressure or headaches caused by tight-fitting glasses. Temple accessory slots on the temple are compatible with attachable lanyards (sold separately) and can also improve airflow when not in use.

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	00720476591832	GS1