Remidio

GUDID 08906096520014

FOP NM-10 is indicated for screening, capture and storage of images of the eye and surrounding area, FOP NM 10 camera is been designed for true colour and monochrome imaging in visible spectrum of light and consists of an incoherent light source. Light from the device is shown into the patient eye & the camera of a smart phone is used to capture images of the eye.

REMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED

Ophthalmic fundus camera
Primary Device ID08906096520014
NIH Device Record Key4f1fd8ea-bc08-4f7c-8467-b9f8e16d443c
Commercial Distribution StatusIn Commercial Distribution
Brand NameRemidio
Version Model Number001
Company DUNS650711448
Company NameREMIDIO INNOVATIVE SOLUTIONS PRIVATE LIMITED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108906096520014 [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 Number4
Public Version Date2020-02-20
Device Publish Date2019-02-03

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