Vortex Surgical Inc.

Basic Information

• Brand Name: Vortex Surgical Inc.
• Primary DI: 00810123483167
• Version / Model: VS0803
• Company Name: Vortex Surgical, Inc.
• Labeler DUNS: 080375891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-04-18
• Public Version: 1
• Public Version Date: 2025-04-28
• Public Version Status: New
• Public Device Record Key: cb35ddb0-d748-4ca6-8e28-e36a5abddbc7

Device Description

Pupillary Transilluminator

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HJM	Transilluminator, Ac-Powered	Ophthalmic	886.1945	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45193	Ophthalmic fibreoptic light instrument, single-use	A sterile, hand-held, ophthalmic surgical instrument with a thin, rigid, insertion portion, that is inserted into the eye during a surgical intervention for the purpose of conducting a field of cold light to the posterior segment of the eye. It is connected through a permanently attached light cable to a light source. It has a fibreoptic bundle core that conducts the light, and may be provided with an atraumatic tip to allow for extraocular manipulation (orbital depression) with transscleral illumination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810123483150	GS1
Primary	00810123483167	GS1