DIGITAL MEDICAL SCOPE

GUDID 04987669101001

NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and video of fundus (including retina, macula and optic disc)

NIDEK CO.,LTD.

Ophthalmic fundus camera

• Primary Device ID: 04987669101001
• NIH Device Record Key: d300130c-596f-4756-9dc3-5fc9fb4c67bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGITAL MEDICAL SCOPE
• Version Model Number: DS-20F
• 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: 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	04987669101001 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

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: 2018-03-29
• Device Publish Date: 2017-01-27

On-Brand Devices [DIGITAL MEDICAL SCOPE]

• 04987669101087: NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and vide
• 04987669101070: The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be u
• 04987669101056: DS-10EA Adapter is designed to connect the control unit of DS-10 and the existing endoscope in t
• 04987669101049: DS-10G is a digital hand-held camera used to record digital photographs and video of the human b
• 04987669101032: DS-10E is a digital hand-held otoscope used to record digital photographs and video of the human
• 04987669101025: DS-10D is a digital hand-held dermatoscope used to record digital photographs and video of the h
• 04987669101018: DS-10A is a digital hand-held anterior scope used to record digital photographs and video of ant
• 04987669101001: NIDEK DS-20 is a digital hand-held eye-fundus camera used to record digital photographs and vide
• 04987669100998: NIDEK DS-10F is a digital hand-held eye-fundus camera used to record digital photographs and vid