Surgical 3D Video Microscope KestrelView II

GUDID 04589698450206

The KV2 is for use as surgical microscope designed to magnify minute structuresin the fields for surgery.

MITAKA KOHKI CO., LTD.

Surgical microscope fluorescent angiography system
Primary Device ID04589698450206
NIH Device Record Keyce95be3b-e296-4562-b9f6-741a80909d43
Commercial Distribution StatusIn Commercial Distribution
Brand NameSurgical 3D Video Microscope KestrelView II
Version Model NumberKV2
Company DUNS692666613
Company NameMITAKA KOHKI CO., LTD.
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
GS104589698450206 [Primary]

FDA Product Code

EPTMicroscope, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-04
Device Publish Date2018-09-03

Devices Manufactured by MITAKA KOHKI CO., LTD.

04589698450602 - 4K3D Video Microscope HawkSight2022-12-08
04589698450251 - Surgical Microscope MM90/YOH2022-12-05
04589698450268 - Surgical Microscope MM80/YOH2022-12-05
04589698450275 - Surgical Microscope MM80/SOH2022-12-05
04589698450534 - Surgical Microscope MM80/SS12022-12-05
04589698450541 - Surgical Microscope MM51/SS12022-12-05
04589698450558 - Surgical Microscope MM90/SS12022-12-05
04589698450572 - Surgical Microscope MM90/SOH2022-12-05

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