GUDID 00697077001742

Amico Diagnostic Incorporated

Direct ophthalmoscope, line-powered
Primary Device ID00697077001742
NIH Device Record Key686081c3-18fc-4cae-82bc-6ee592871a59
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDS-UV1-CHFH-DXX
Company DUNS203163290
Company NameAmico Diagnostic Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100697077001742 [Primary]

FDA Product Code

HLIOphthalmoscope, Ac-Powered

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 Date2016-09-24

Devices Manufactured by Amico Diagnostic Incorporated

00697077003050 - Amico Diagnostic, Inc.2024-09-26 Diagnostic Station Ophthalmoscope & Otoscope LED, Spec Dispenser, Aneroid & Adult Cuff, Thermometer, Grey Wallboard Ophthalmosco
00697077003036 - NA2024-07-02
00697077003029 - NA2024-05-10
00697077002237 - NA2023-08-04
00697077002985 - NA2023-08-04
00697077002992 - NA2023-08-04
00697077003005 - NA2023-08-04
00697077003012 - NA2023-08-04

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