System Table

Basic Information

• Brand Name: System Table
• Primary DI: 04987669101490
• Version / Model: ST-600
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-26
• Public Version: 1
• Public Version Date: 2019-04-03
• Public Version Status: New
• Public Device Record Key: f797b8a7-e58f-4f75-9c4f-7af3f3c88be1
• Distribution End Date: 2019-03-29

Device Description

The ST-600 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually operated refractor such as the RT-600 or SLY-100 is installed. The system table allows chart presenting devices (SSC-370, CP-770, SC-1600 series), auto refractometers, lensmeters (LM-1800 series, LM-7 series) to be combined into an ophthalmic workstation. The system table consists of a refractor head lift arm equipped with a refractor head and a motorized main table. While compact, it includes a motorized table with a stroke up to 200 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 35 types of trial lenses.

Device Characteristics

• Single Use: No
• 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: 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	04987669101490	GS1

Customer Contacts

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