Superflex Collection

Basic Information

• Brand Name: Superflex Collection
• Primary DI: 00676190399653
• Version / Model: SF-552 CHARCOAL BLACK
• Company Name: WestGroupe Optical Inc
• Labeler DUNS: 204096080
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-10
• Public Version: 1
• Public Version Date: 2020-07-20
• Public Version Status: New
• Public Device Record Key: fb64c9f9-95dd-4b47-9915-4c81c942c4a5

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: Yes
• 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: No
• 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
Primary	00676190399653	GS1