IS-5000

Basic Information

• Brand Name: IS-5000
• Primary DI: 00852683007148
• Version / Model: 23070-11-001
• Company Name: TOPCON MEDICAL SYSTEMS, INC.
• Labeler DUNS: 053547238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 2
• Public Version Date: 2023-05-25
• Public Version Status: Update
• Public Device Record Key: b537c84c-c5c8-4188-b882-e37e365c44f2

Device Description

IS-5000 INSTRUMENT STAND 110/120 VOLT; AC-Powered Ophthalmic Instrument Stand

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
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	886.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36255	Static ophthalmic equipment stand, manually-adjusted	A device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It may have a manually-operated height adjustment function (e.g., a hydraulic foot pump or adjustable threaded column) enabling the user to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852683007148	GS1