S4 Optik

Basic Information

• Brand Name: S4 Optik
• Primary DI: 00628308210107
• Version / Model: 2500-CB-H
• Company Name: INNOVA Medical Ophthalmics Inc
• Labeler DUNS: 243325332
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-20
• Public Version: 2
• Public Version Date: 2026-01-27
• Public Version Status: Update
• Public Device Record Key: 1aa90dc8-64ab-46cf-8ca0-52cf4f758df5

Device Description

S4OPTIK Combination Chair & Stand - Model 2500-CB-H

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
HME	Chair, Ophthalmic, Ac-Powered	Ophthalmic	886.1140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15723	Ophthalmic chair, line-powered	A mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628308210107	GS1