v900L Vision System

Basic Information

• Brand Name: v900L Vision System
• Primary DI: 00867009000406
• Version / Model: v900L
• Company Name: SYRIS SCIENTIFIC LLC
• Labeler DUNS: 043184204
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-04
• Public Version: 3
• Public Version Date: 2020-07-17
• Public Version Status: Update
• Public Device Record Key: fe925452-c9d9-4246-97da-47bf3903d0b6
• Distribution End Date: 2020-07-15

Device Description

Polarized Illumination System with magnification for enhanced visualization during dermatology and cosmetic procedures.

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: 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
KZF	Device, Medical Examination, Ac Powered	General Hospital	880.6320	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	00867009000406	GS1

Customer Contacts

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