GUDID 04582275250374

KONAN MEDICAL, INC.

Anterior eye segment analysis system analyser
Primary Device ID04582275250374
NIH Device Record Key44ba38ef-71eb-46c8-b66f-d2e145aaf190
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNSPC
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
GS104582275250374 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by KONAN MEDICAL, INC.

04582275250671 - NA2023-10-05
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
04582275250374 - NA2018-07-06

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