CEM Viewer for NAVIS-EX

GUDID 04987669101353

The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the examination data of the SPECULAR MICROSCOPE CEM-530 or

NIDEK CO.,LTD.

Eye anterior segment analyser software

• Primary Device ID: 04987669101353
• NIH Device Record Key: c874967e-1f3b-4724-9a0e-c75682cc9e18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEM Viewer for NAVIS-EX
• Version Model Number: 1.1
• 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: 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: 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	04987669101353 [Primary]

FDA Product Code

• NFJ: System, Image Management, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-08-03

On-Brand Devices [CEM Viewer for NAVIS-EX]

• 04987669101353: The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the e
• 04987669607350: The CEM Viewer for NAVIS-EX software (hereafter referred to as CEM Viewer) is used to view the e