GUDID 04582275250657

KONAN MEDICAL, INC.

Eye anterior segment analyser
Primary Device ID04582275250657
NIH Device Record Key5eaf7dd0-b143-4d54-ae4a-f1c8d0607466
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCC 20 rc
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 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
GS104582275250657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFJSystem, image management, ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-05
Device Publish Date2021-06-25

Devices Manufactured by KONAN MEDICAL, INC.

04582275250671 - NA2023-10-05
04582275250664 - NA2022-04-15
04582275250657 - NA2021-07-05
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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