GUDID 00697077002565

Amico Diagnostic Incorporated

Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Direct ophthalmoscope, line-powered Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer
Primary Device ID00697077002565
NIH Device Record Keyf0b0c252-5ecc-4a8d-88d1-eaf5cb437e18
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberDS-UF2-CHFH-DAO
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
GS100697077002565 [Primary]

FDA Product Code

HLIOphthalmoscope, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-27
Device Publish Date2020-07-17

Devices Manufactured by Amico Diagnostic Incorporated

00697077003029 - NA2024-05-10
00697077002237 - NA2023-08-04
00697077002985 - NA2023-08-04
00697077002992 - NA2023-08-04
00697077003005 - NA2023-08-04
00697077003012 - NA2023-08-04
00697077002978 - NA2023-07-13
00697077002961 - NA2023-04-26

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