GUDID 04582275270037

KONAN MEDICAL USA, INC.

Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode Visual evoked-potential electrode
Primary Device ID04582275270037
NIH Device Record Keyd679f809-ee0b-4afe-85e8-0092f303b7eb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberM339 DME CARBON CL
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS104582275270037 [Primary]

FDA Product Code

GXYELECTRODE, CUTANEOUS

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 Date2016-09-23

Devices Manufactured by KONAN MEDICAL USA, INC.

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