ColoFlex™ UHD MP-0006-HDC

GUDID 03760187910055

MAUNA KEA TECHNOLOGIES

Confocal endomicroscopy system probe
Primary Device ID03760187910055
NIH Device Record Key3b6c69d4-5d69-4413-889a-ae4f59ba763d
Commercial Distribution StatusIn Commercial Distribution
Brand NameColoFlex™ UHD
Version Model Number211-0134
Catalog NumberMP-0006-HDC
Company DUNS394136118
Company NameMAUNA KEA TECHNOLOGIES
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com
Phone+33170080967
Emailsupport@maunakeatech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103760187910055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWNConfocal Optical Imaging

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760187910055]

High-level Disinfectant


[03760187910055]

High-level Disinfectant


[03760187910055]

High-level Disinfectant


[03760187910055]

High-level Disinfectant


[03760187910055]

High-level Disinfectant


[03760187910055]

High-level Disinfectant


[03760187910055]

High-level Disinfectant


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2026-03-20
Device Publish Date2016-09-24

Devices Manufactured by MAUNA KEA TECHNOLOGIES

03760187910055 - ColoFlex™ UHD2026-03-20
03760187910055 - ColoFlex™ UHD2026-03-20
03760187910079 - GastroFlex™ UHD2026-03-20
03760187913001 - Cellvizio® I.V.E.2024-03-07
03760187910772 - AQ-Flex™ 19-C2023-02-17
03760187912004 - Cellvizio® I.V.E.2020-05-25
03760187912011 - AlveoFlex™ N2020-05-25
03760187912028 - GastroFlex™ N2020-05-25
03760187912035 - ColoFlex™ N2020-05-25

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