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 ID04987669101001
NIH Device Record Keyd300130c-596f-4756-9dc3-5fc9fb4c67bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIGITAL MEDICAL SCOPE
Version Model NumberDS-20F
Company DUNS690635461
Company NameNIDEK CO.,LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-223-9044
Emailinfo@nidek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104987669101001 [Primary]

FDA Product Code

PJZCamera, Ophthalmic, General-Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-01-27

On-Brand Devices [DIGITAL MEDICAL SCOPE]

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

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