Skullerz

Basic Information

• Brand Name: Skullerz
• Primary DI: 00720476500650
• Version / Model: DELLENGER-AF
• Catalog Number: 50065
• Company Name: Ergodyne
• Labeler DUNS: 108665142
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-13
• Public Version: 1
• Public Version Date: 2023-07-21
• Public Version Status: New
• Public Device Record Key: d41d27a9-0949-4103-b837-ed967734d544

Device Description

Skullerz DELLENGER Anti-Fog Safety Glasses feature adjustable temples that shift up or down and lock into place for a custom fit on a variety of face sizes. 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. The rimless design makes for a lightweight and comfortable fit and maximizes a full field of vision. A contoured nose bridge won’t slip or pinch and the flex-fit temples reduce pressure and provide stay-put all-day comfort.

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	00720476500650	GS1