SYSTEM TABLE

Basic Information

• Brand Name: SYSTEM TABLE
• Primary DI: 04987669100806
• Version / Model: ST-5100
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-20
• Public Version: 1
• Public Version Date: 2018-05-21
• Public Version Status: New
• Public Device Record Key: fe9ae642-4741-4061-8585-a9804b114d10

Device Description

The ST-5100 is the system table on which the NIDEK REFRACTOR RT-5100 is installed. The table allows the SSC-330/350, AR/ARK series, and LM-500/LM-600 series/LM-1800 series to be combined into an ophthalmic workstation. The table is composed of a refractor arm, motorized main table, and side table. The main table, which is electrically extendable up to 180 mm, has an RT arm, rotatable with one touch, simple operation, and a tray to hold an auto refractometer (AR/ARK series). The side table is for installing the SSC-330/350 or LM-500/LM-600 series/LM-1800 series. It is equipped with drawers for trial lenses and space for a computer and printer.

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
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	886.4855	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13959	Instrument table	A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100806	GS1

Customer Contacts

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