Primary Device ID | 03760187912042 |
NIH Device Record Key | f9761571-2556-407d-b57a-3a7013cb63fe |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CystoFlex™ R N |
Version Model Number | FP-10032 |
Company DUNS | 394136118 |
Company Name | MAUNA KEA TECHNOLOGIES |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +33170080967 |
support@maunakeatech.com | |
Phone | +33170080967 |
support@maunakeatech.com | |
Phone | +33170080967 |
support@maunakeatech.com | |
Phone | +33170080967 |
support@maunakeatech.com | |
Phone | +33170080967 |
support@maunakeatech.com | |
Phone | +33170080967 |
support@maunakeatech.com | |
Phone | +33170080967 |
support@maunakeatech.com | |
Phone | +33170080967 |
support@maunakeatech.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03760187912042 [Primary] |
OWN | Confocal Optical Imaging |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03760187912042]
Hydrogen Peroxide
[03760187912042]
Hydrogen Peroxide
[03760187912042]
Hydrogen Peroxide
[03760187912042]
Hydrogen Peroxide
[03760187912042]
Hydrogen Peroxide
[03760187912042]
Hydrogen Peroxide
[03760187912042]
Hydrogen Peroxide
[03760187912042]
Hydrogen Peroxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-25 |
Device Publish Date | 2020-05-15 |
03760187913001 - Cellvizio® I.V.E. | 2024-03-07 |
03760187910772 - AQ-Flex™ 19-C | 2023-02-17 |
03760187912004 - Cellvizio® I.V.E. | 2020-05-25 |
03760187912011 - AlveoFlex™ N | 2020-05-25 |
03760187912028 - GastroFlex™ N | 2020-05-25 |
03760187912035 - ColoFlex™ N | 2020-05-25 |
03760187912042 - CystoFlex™ R N | 2020-05-25 |
03760187912042 - CystoFlex™ R N | 2020-05-25 |
03760187912059 - AQ-Flex™ 19 N | 2020-05-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CYSTOFLEX 79326279 not registered Live/Pending |
AXESS VISION TECHNOLOGY 2021-10-22 |
![]() CYSTOFLEX 79196279 not registered Dead/Abandoned |
AXESS VISION TECHNOLOGY 2016-08-16 |