GUDID 04582275270020

KONAN MEDICAL USA, INC.

Vision electrophysiology analysis system
Primary Device ID04582275270020
NIH Device Record Key0fbbed02-abad-440c-b253-2de5d96b6829
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberEV-001
Company DUNS788439219
Company NameKONAN MEDICAL USA, INC.
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104582275270020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWEStimulator, photic, evoked response

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by KONAN MEDICAL USA, INC.

04582275270068 - NA2023-06-23
04582275270051 - N/A2019-09-17
04582275270020 - NA2018-07-06
04582275270020 - NA2018-07-06
04582275270037 - NA2018-03-29
04582275270044 - NA2018-03-29

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