CystoFlex™UHD R MP-0013-HCYS-CK

GUDID 00827002472754

MAUNA KEA TECHNOLOGIES

Confocal endomicroscopy system probe
Primary Device ID00827002472754
NIH Device Record Key11b27f5d-3425-482a-b2b8-21af02d50b5f
Commercial Distribution Discontinuation2020-04-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCystoFlex™UHD R
Version Model Number211-0147
Catalog NumberMP-0013-HCYS-CK
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002472754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWNConfocal Optical Imaging

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00827002472754]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-07
Device Publish Date2016-12-12

Devices Manufactured by MAUNA KEA TECHNOLOGIES

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
03760187912042 - CystoFlex™ R N2020-05-25
03760187912059 - AQ-Flex™ 19 N2020-05-25

Trademark Results [CystoFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CYSTOFLEX
CYSTOFLEX
79326279 not registered Live/Pending
AXESS VISION TECHNOLOGY
2021-10-22
CYSTOFLEX
CYSTOFLEX
79196279 not registered Dead/Abandoned
AXESS VISION TECHNOLOGY
2016-08-16

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