Malibu

Basic Information

• Brand Name: Malibu
• Primary DI: 06974213565783
• Version / Model: 6223
• Company Name: WENZHOU TIDE-OPTICAL CO.,LTD
• Labeler DUNS: 539961200
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-13
• Public Version: 1
• Public Version Date: 2026-04-21
• Public Version Status: New
• Public Device Record Key: f9c55240-1ba6-4acd-b525-3fb36bb605e9

Device Description

Sunglasses, PC material, Ready-to wear type(51-21-140)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• 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
HDY	Dilator, Cervical, Hygroscopic-Laminaria	Obstetrics/Gynecology	884.4260	2

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
Package	16974213560488	GS1		12	In Commercial Distribution
Primary	06974213565783	GS1
Package	26974213560133	GS1		25	In Commercial Distribution