GUDID 04582275250664

KONAN MEDICAL, INC.

Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser Eye anterior segment analyser
Primary Device ID04582275250664
NIH Device Record Keye3d776b1-ca21-49a9-ad72-b5226036354f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCellChek 20-1
Company DUNS690768619
Company NameKONAN MEDICAL, 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
GS104582275250664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQEMicroscope, specular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-15
Device Publish Date2022-04-07

Devices Manufactured by KONAN MEDICAL, INC.

04582275250671 - NA2023-10-05
04582275250664 - NA2022-04-15
04582275250664 - NA2022-04-15
04582275250657 - NA2021-07-05
04582275250626 - NA2020-04-10
04582275250107 - NA2020-02-13
04582275250428 - NA2020-02-07
04582275250619 - N/A2020-01-21
04582275250374 - NA2018-07-06

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