ETNIA EYEWEAR CULTURE

Basic Information

• Brand Name: ETNIA EYEWEAR CULTURE
• Primary DI: 08435646278315
• Version / Model: 8 WOOLF 46O 15 HV/PK
• Company Name: Etnia Barcelona, Llc.
• Labeler DUNS: 148350593
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 2
• Public Version Date: 2023-02-24
• Public Version Status: Update
• Public Device Record Key: 56dd647b-271c-4597-96de-3f880c7e643f

Device Description

Frame Spectacle

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: Yes
• Has Lot/Batch Number: Yes
• 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
HQZ	Frame, Spectacle	Ophthalmic	886.5842	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32816	Spectacle frame	An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18435646278312	GS1	BOX	10	In Commercial Distribution
Primary	08435646278315	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]