Sterilized Endophoto Probe(23G/Coaxial)

GUDID 04987669100400

It is used to deliver the laser beam from the main laser device into the eye. The sterilized endophoto probe comes already sterilized at the factory a

NIDEK CO.,LTD.

Ophthalmic laser system beam guide

• Primary Device ID: 04987669100400
• NIH Device Record Key: 0d5d472d-23fb-4660-8315-0508c8088320
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilized Endophoto Probe(23G/Coaxial)
• Version Model Number: 11143-7300
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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 Dimensions

• Needle Gauge: 23 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987669100400 [Package]; Contains: 04987669101315; Package: Box [5 Units]; In Commercial Distribution
GS1	04987669101315 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-05-24
• Device Publish Date: 2018-04-23

Devices Manufactured by NIDEK CO.,LTD.

• 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.
• 04987669200780 - IOL-Station: 2023-07-18 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica
• 04987669100844 - IOL-Station: 2023-06-20 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica