OPHTHALMOSCOPE

GUDID 04987669100561

The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red.

NIDEK CO.,LTD.

Direct ophthalmoscope, line-powered

• Primary Device ID: 04987669100561
• NIH Device Record Key: 3091c2ad-24bd-4c94-b662-9f7c14c6c796
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPHTHALMOSCOPE
• Version Model Number: F-10
• Company DUNS: 690635461
• Company Name: NIDEK CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987669100561 [Primary]

FDA Product Code

• MYC: Ophthalmoscope, Laser, Scanning

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: 2018-05-21
• Device Publish Date: 2018-04-20

Devices Manufactured by NIDEK CO.,LTD.

• 04987669204610 - Open-field Refraction System: 2026-01-16 The PHANTOM is a device that performs objective refraction and subjective refraction for the patient's eyes.
• 04987669204917 - Open-field Refraction System: 2026-01-16 Control Box is a combined examination device that presents optical targets for both distant and near vision acuity testing, and
• 04987669200018 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
• 04987669200049 - Pachymetry probe (45° fixed type): 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan.
• 04987669200070 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200094 - Pachymetry probe: 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200100 - Pachymetry probe (45° fixed type): 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000.
• 04987669200117 - A-scan probe: 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500.