Primary Device ID | 03760187912004 |
NIH Device Record Key | ef89069f-47bc-4ac7-a9f0-9ebcca0a565e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cellvizio® I.V.E. |
Version Model Number | FP-10001 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03760187912004 [Primary] |
OWN | Confocal Optical Imaging |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-05-25 |
Device Publish Date | 2020-05-15 |
03760187912004 | FP-10001 |
03760187913001 | FP-10001 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CELLVIZIO 79002769 3011583 Live/Registered |
MAUNA KEA TECHNOLOGIES 2004-03-05 |