Eighteeth

Basic Information

• Brand Name: Eighteeth
• Primary DI: 06941877822248
• Version / Model: Wireless Z+
• Catalog Number: 5080909
• Company Name: Changzhou Sifary Medical Technology Co., Ltd.
• Labeler DUNS: 560366787
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-17
• Public Version: 1
• Public Version Date: 2025-04-25
• Public Version Status: New
• Public Device Record Key: 37c7e657-542a-4a05-a49d-df47e7f03c23

Device Description

Surgical Headlight is worn on the doctor's head for the lighting of the parts for diagnosis and examination of patients. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

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
EBA	Light, Surgical Headlight	Dental	872.4630	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46807	Head-worn lamp	An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06941877822248	GS1