SPACE SAVING CHART

Basic Information

• Brand Name: SPACE SAVING CHART
• Primary DI: 04987669100646
• Version / Model: SSC-370
• 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: 2
• Public Version Date: 2019-07-22
• Public Version Status: Update
• Public Device Record Key: f3a25178-720c-4c4a-a222-407c9156f386

Device Description

The space saving chart SSC-370 achieves the refraction distance of 5 m within an installation distance*1 of 1.1 m. The SSC-370 is a chart presenting device. The built-in optical system presents charts toward the back of the chart window. The VA (visual acuity) charts are composed of the four types of letters, Tumbling E, number, and children.

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
HOX	Chart, Visual Acuity	Ophthalmic	886.1150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16800	Vision testing/training chart	An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100646	GS1

Customer Contacts

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