N/A

GUDID 04582275250619

KONAN MEDICAL, INC.

General-purpose surgical microscope
Primary Device ID04582275250619
NIH Device Record Key209c7e95-0ebe-4147-984d-9de2889f0e62
Commercial Distribution Discontinuation2019-05-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameN/A
Version Model NumberPOM
Company DUNS690768619
Company NameKONAN MEDICAL, 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 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
GS104582275250619 [Primary]

FDA Product Code

HRMMICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-21
Device Publish Date2017-11-27

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
04582275250619 - N/A2020-01-21
04582275250374 - NA2018-07-06

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