GUDID 04582275270068

KONAN MEDICAL USA, INC.

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Primary Device ID04582275270068
NIH Device Record Key4138f164-bfa4-4dd3-8c34-283d038f8670
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCOLORDX CCT HD
Company DUNS788439219
Company NameKONAN MEDICAL USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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
GS104582275270068 [Primary]

FDA Product Code

HITTester, color vision

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-23
Device Publish Date2023-06-15

Devices Manufactured by KONAN MEDICAL USA, INC.

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