Primary Device ID | B475FKCL0 |
NIH Device Record Key | 44870507-05c4-4231-8a05-0aff92a98a25 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FLUOCART |
Version Model Number | FK-CL |
Company DUNS | 260631677 |
Company Name | FLUOPTICS |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B475FKCL0 [Primary] |
BWN | Table And Attachments, Operating-Room |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-02-08 |
Device Publish Date | 2022-01-31 |
B475FBLXR0 - FLUOBEAM LX Red | 2024-05-14 Fluorescence imaging system |
B475FMSA0 - FLUOPOD | 2023-10-09 |
B475FKCL0 - FLUOCART | 2022-02-08 |
B475FKCL0 - FLUOCART | 2022-02-08 |
B475FBLM0 - FLUOBEAM LM | 2021-02-26 Fluorescence imaging system |
B475LXHO0 - FLUOCLIP | 2021-02-26 |
B475FBLX0 - FLUOBEAM LX | 2019-09-13 Fluorescence imaging system |
B475FB800CLV190 - FLUOBEAM 800 | 2018-07-26 |
B475FC800CLV190 - FLUOCASE 800 | 2018-07-26 |