IOL-Station

GUDID 04987669200780

The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optical Biometer AL-Scan, and Specular Microscope CEM-530, and offers functions such as IOL power calculation, aspheric IOL recommendation, simulation of patient's view with IOL, and printing of Cataract Summary. It provides data required for cataract surgery and helps explanations to the patients.

NIDEK CO.,LTD.

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• Primary Device ID: 04987669200780
• NIH Device Record Key: 928b81d8-6eae-4267-883a-98118ef34a66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IOL-Station
• Version Model Number: 1.21
• Company DUNS: 690635461
• Company Name: NIDEK CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com
• Phone: 1-800-223-9044
• Email: info@nidek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987669200780 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-18
• Device Publish Date: 2023-07-10

On-Brand Devices [IOL-Station]

• 04987669100844: The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Ana
• 04987669200780: The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Ana