AIOBIO

Basic Information

• Brand Name: AIOBIO
• Primary DI: 08800043200212
• Version / Model: LINKDENS VU
• Company Name: AIOBIO CO.,LTD
• Labeler DUNS: 694894136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-10
• Public Version: 1
• Public Version Date: 2024-07-18
• Public Version Status: New
• Public Device Record Key: 9f790c0a-903c-45d7-8387-d91981efa266

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: 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
EAZ	Light, Operating, Dental	Dental	872.4630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12352	Fibreoptic dental light	A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a fibreoptic cable to illuminate the site of a dental examination or procedure. The illumination is produced by the light source of the device, a dedicated light bulb, and is transmitted via the fibreoptic cable which is attached to a dental handpiece held, or a headband worn, by dental staff. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800043200212	GS1