Universal Adapter 10-15mm

GUDID 04589698450466

This device is designed to be used with the endoscope holder "Point Setter" manufactured by Mitaka Kohki Co., Ltd.

MITAKA KOHKI CO., LTD.

Surgical instrument assist arm system, power-adjusted
Primary Device ID04589698450466
NIH Device Record Key7d5a605d-ae1d-4d03-a019-9b88ccd26f46
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Adapter 10-15mm
Version Model NumberPS-BU-045
Company DUNS692666613
Company NameMITAKA KOHKI CO., LTD.
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 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
GS104589698450466 [Primary]

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04589698450466]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-13
Device Publish Date2019-02-06

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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